Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-29 @ 6:18 AM
Study NCT ID:
NCT00878995
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2009-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C004648', 'term': 'testosterone enanthate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'melmoore@utmb.edu', 'phone': '409-772-8707', 'title': 'Melinda Sheffield-Moore', 'organization': 'University of Texas Medical Branch'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Fever', 'notes': 'Fever requiring anitbiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Neutropenic Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Altered Mental State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Vesicovaginal Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Metastatic Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Anemia Requiring Tranfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Duodenal Ulcer', 'notes': 'Duodenal Ulcer that caused anemia and required a blood tranfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Anaphylactic shock', 'notes': 'Anaphylactic shock to chemotherapy agen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Sycope', 'notes': 'Syncope resulting in a fall with broken arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.31', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '7.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Reporting data for the 22 completing subjects only, since this data is reported as change over time.'}, {'type': 'SECONDARY', 'title': 'Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '81.77', 'spread': '42.58', 'groupId': 'OG000'}, {'value': '122.50', 'spread': '70.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.', 'unitOfMeasure': 'Newton-Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.'}, {'type': 'SECONDARY', 'title': 'Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '76.75', 'spread': '25.22', 'groupId': 'OG000'}, {'value': '118.26', 'spread': '62.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.', 'unitOfMeasure': 'Newton-Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.'}, {'type': 'SECONDARY', 'title': 'Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '137.60', 'spread': '86.77', 'groupId': 'OG000'}, {'value': '169.0', 'spread': '99.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.', 'unitOfMeasure': 'Watts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer.'}, {'type': 'SECONDARY', 'title': 'Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '126.93', 'spread': '57.05', 'groupId': 'OG000'}, {'value': '157.90', 'spread': '84.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.', 'unitOfMeasure': 'Watts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.'}, {'type': 'SECONDARY', 'title': 'Body Weight as Measured by Scale at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '65.98', 'spread': '25.49', 'groupId': 'OG000'}, {'value': '63.11', 'spread': '17.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Body weight in kilograms as measured by a scale at the baseline visit.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '24 subjects began the study. Each subjects was able to complete this outcome measure at the baseline time point.'}, {'type': 'SECONDARY', 'title': 'Body Weight as Measured by Scale at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '63.93', 'spread': '24.79', 'groupId': 'OG000'}, {'value': '62.59', 'spread': '17.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '22 subjects completed this outcome measure at the 7 week time point. 24 subjects started the study, 2 subjects dis-enrolled after the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '1329.20', 'spread': '359.94', 'groupId': 'OG000'}, {'value': '1310.81', 'spread': '398.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.', 'unitOfMeasure': 'kilo-calories per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '24 subjects completed this outcome measure at the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '1338.10', 'spread': '281.77', 'groupId': 'OG000'}, {'value': '1260.98', 'spread': '222.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.', 'unitOfMeasure': 'kilo-calories per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 19 subjects were able to complete this outcome measure at this time point due to problems related to their cancer.'}, {'type': 'SECONDARY', 'title': 'Physical Activity Levels as Measured by the ActiGraph Accelerometer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '73.55', 'spread': '15.78', 'groupId': 'OG000'}, {'value': '74.74', 'spread': '9.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through study completion,up to 7 weeks', 'description': 'Physical activity is reported as % time sedentary for the entire 7 week study.', 'unitOfMeasure': '% time sedentary', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from only 12 subjects is presented due to a compliance issue with wearing the activity monitoring belts. A threshold was set to determine if subject was wearing the belt as directed.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '67.02', 'spread': '67.13', 'groupId': 'OG000'}, {'value': '260.69', 'spread': '251.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '64.15', 'spread': '50.36', 'groupId': 'OG000'}, {'value': '191.17', 'spread': '206.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '21.62', 'spread': '15.61', 'groupId': 'OG000'}, {'value': '15.71', 'spread': '7.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '20.63', 'spread': '13.01', 'groupId': 'OG000'}, {'value': '11.66', 'spread': '8.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '3.11', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '2.13', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '3.62', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '2.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '4.30', 'spread': '4.70', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '2.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '10.48', 'spread': '24.43', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '2.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '14.56', 'spread': '26.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '3.13', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '12.62', 'spread': '24.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '11.04', 'spread': '15.94', 'groupId': 'OG000'}, {'value': '43.99', 'spread': '59.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '8.89', 'spread': '5.48', 'groupId': 'OG000'}, {'value': '23.09', 'spread': '36.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '6.57', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '21.61', 'spread': '36.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '9.97', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '18.16', 'spread': '25.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '14.57', 'spread': '9.93', 'groupId': 'OG000'}, {'value': '16.62', 'spread': '8.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '11.45', 'spread': '5.90', 'groupId': 'OG000'}, {'value': '12.34', 'spread': '7.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '13.35', 'spread': '13.99', 'groupId': 'OG000'}, {'value': '94.52', 'spread': '200.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 10 (IL-10) 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[{'categories': [{'measurements': [{'value': '12.84', 'spread': '13.25', 'groupId': 'OG000'}, {'value': '82.46', 'spread': '184.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone 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'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '4.36', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '28.36', 'spread': '54.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '20.50', 'spread': '39.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy 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{'type': 'SECONDARY', 'title': 'Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard 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'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '33.52', 'spread': '71.72', 'groupId': 'OG000'}, {'value': '12.22', 'spread': '6.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.', 'unitOfMeasure': 'picogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood was collected for this outcome from only 18 subjects.'}, {'type': 'SECONDARY', 'title': 'Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '20513.50', 'spread': '13044.73', 'groupId': 'OG000'}, {'value': '18227.33', 'spread': '10470.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '24 subjects were able to complete this outcome measure at the baseline study visit.'}, {'type': 'SECONDARY', 'title': 'Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '17616.58', 'spread': '12513.32', 'groupId': 'OG000'}, {'value': '16776.60', 'spread': '10989.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '24 subjects began the study, 2 were dis-enrolled, 22 subjects finished the study. All 22 subjects completed this outcome measure at 7 weeks.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '47.73', 'spread': '27.87', 'groupId': 'OG000'}, {'value': '52.22', 'spread': '23.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects completed this questionnaire at this time point.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '52.73', 'spread': '22.73', 'groupId': 'OG000'}, {'value': '46.50', 'spread': '14.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '21 subjects completed this questionnaire at this time point.'}, {'type': 'SECONDARY', 'title': 'Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '12.73', 'spread': '25.48', 'groupId': 'OG000'}, {'value': '21.40', 'spread': '21.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.\n\nThere 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.\n\nThe range of the total score is -24 to 96, with the higher the number meaning more fatigue.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '21 subjects completed this questionnaire at this time point.'}, {'type': 'SECONDARY', 'title': 'Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '18.73', 'spread': '24.18', 'groupId': 'OG000'}, {'value': '26.11', 'spread': '19.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': "Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.\n\nThere 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.\n\nThe range of the total score is -24 to 96, with the higher the number meaning more fatigue.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects completed this questionnaire at this time point.'}, {'type': 'SECONDARY', 'title': 'Mood Measured by Profile of Mood States at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '30.73', 'spread': '50.67', 'groupId': 'OG000'}, {'value': '32.55', 'spread': '23.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all\' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '22 subjects completed this questionnaire at this time point.'}, {'type': 'SECONDARY', 'title': 'Mood as Measured by Profile of Mood States at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '28.82', 'spread': '44.18', 'groupId': 'OG000'}, {'value': '35.78', 'spread': '36.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all\' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects completed this questionnaire at this time point.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '18.83', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '30.48', 'spread': '31.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '19 subjects completed this questionnaire at this time point.'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '20.11', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '24.97', 'spread': '20.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 weeks', 'description': 'Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '20 subjects completed this questionnaire at this time point.'}, {'type': 'SECONDARY', 'title': '1-year Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'OG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year post study', 'description': 'Number of participants who survived one year post study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '12 subjects started each group. 2 subjects withdrew after baseline from the testosterone group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'FG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}], 'periods': [{'title': 'Baseline Study - Midpoint Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Baseline Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'comment': '2 subjects dropped after the baseline study. They decided to seek treatment closer to home.', 'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Midpoint Study - Post Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited via UTMB Oncology, Radiation Oncology, and ENT clinics by study physicians.', 'preAssignmentDetails': 'Subjects began study before beginning chemotherapy and/or radiation therapy. 28 subjects enrolled total. 4 subjects withdrew before beginning the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I: Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n\nStandard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone'}, {'id': 'BG001', 'title': 'Arm II: Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks.\n\nArm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '7.97', 'groupId': 'BG000'}, {'value': '48.66', 'spread': '12.26', 'groupId': 'BG001'}, {'value': '51.44', 'spread': '10.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2009-04-08', 'resultsFirstSubmitDate': '2017-09-26', 'studyFirstSubmitQcDate': '2009-04-08', 'lastUpdatePostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-08', 'studyFirstPostDateStruct': {'date': '2009-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.'}], 'secondaryOutcomes': [{'measure': 'Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline', 'timeFrame': 'Baseline', 'description': 'Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.'}, {'measure': 'Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.'}, {'measure': 'Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline.', 'timeFrame': 'Baseline', 'description': 'Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.'}, {'measure': 'Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks', 'timeFrame': '7 weeks', 'description': 'Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.'}, {'measure': 'Body Weight as Measured by Scale at Baseline', 'timeFrame': 'Baseline', 'description': 'Body weight in kilograms as measured by a scale at the baseline visit.'}, {'measure': 'Body Weight as Measured by Scale at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.'}, {'measure': 'Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline', 'timeFrame': 'Baseline', 'description': 'Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.'}, {'measure': 'Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks', 'timeFrame': '7 weeks', 'description': 'Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.'}, {'measure': 'Physical Activity Levels as Measured by the ActiGraph Accelerometer', 'timeFrame': 'through study completion,up to 7 weeks', 'description': 'Physical activity is reported as % time sedentary for the entire 7 week study.'}, {'measure': 'Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'Baseline', 'description': 'Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline.', 'timeFrame': 'baseline', 'description': 'Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks.', 'timeFrame': '7 weeks', 'description': 'Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.'}, {'measure': 'Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline', 'timeFrame': 'baseline', 'description': 'Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit'}, {'measure': 'Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks', 'timeFrame': '7 weeks', 'description': 'Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit.'}, {'measure': 'Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline', 'timeFrame': 'baseline', 'description': 'The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99.'}, {'measure': 'Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks', 'timeFrame': '7 weeks', 'description': 'The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99'}, {'measure': 'Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline', 'timeFrame': 'Baseline', 'description': "Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.\n\nThere 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.\n\nThe range of the total score is -24 to 96, with the higher the number meaning more fatigue."}, {'measure': 'Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks', 'timeFrame': '7 weeks', 'description': "Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.\n\nThere 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.\n\nThe range of the total score is -24 to 96, with the higher the number meaning more fatigue."}, {'measure': 'Mood Measured by Profile of Mood States at Baseline', 'timeFrame': 'baseline', 'description': 'Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all\' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).'}, {'measure': 'Mood as Measured by Profile of Mood States at 7 Weeks', 'timeFrame': '7 weeks', 'description': 'Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all\' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).'}, {'measure': 'Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline', 'timeFrame': 'Baseline', 'description': 'Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).'}, {'measure': 'Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks', 'timeFrame': '7 weeks', 'description': 'Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).'}, {'measure': '1-year Survival', 'timeFrame': '1 year post study', 'description': 'Number of participants who survived one year post study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage IIB cervical cancer', 'stage III cervical cancer', 'recurrent cervical cancer', 'cachexia', 'advanced head/neck carcinoma', 'recurrent head/neck carcinoma'], 'conditions': ['Cachexia', 'Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '31391011', 'type': 'DERIVED', 'citation': 'Scott JM, Dillon EL, Kinsky M, Chamberlain A, McCammon S, Jupiter D, Willis M, Hatch S, Richardson G, Danesi C, Randolph K, Durham W, Wright T, Urban R, Sheffield-Moore M. Effects of adjunct testosterone on cardiac morphology and function in advanced cancers: an ancillary analysis of a randomized controlled trial. BMC Cancer. 2019 Aug 7;19(1):778. doi: 10.1186/s12885-019-6006-5.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in patients with cachexia caused by cancer.\n\nPURPOSE: This randomized phase I trial is studying whether testosterone administered during standard of care chemotherapy and/or radiation works by helping patients with squamous cell carcinoma to maintain their body weight and muscle size and strength during treatment.', 'detailedDescription': 'OBJECTIVES:\n\n* To determine the effect of testosterone therapy on lean body mass and muscle strength in patients with advanced or recurrent squamous cell carcinoma.\n* To determine the testosterone therapy on inflammatory biomarkers in patients with advanced or recurrent squamous cell carcinoma.\n\nOUTLINE: Patients are stratified according to age and disease stage. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo testosterone intramuscularly (IM) weekly for 7 weeks.\n* Arm II: Patients receive standard of care chemotherapy and/or radiation and testosterone IM weekly for 7 weeks.\n\nPatients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope metabolic studies, indirect calorimetry studies, and assessment of their physical activity level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life questionnaires.\n\nBlood, muscle tissue, and urine samples are collected periodically for laboratory studies. Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by immunoassay.\n\nAfter completion of study treatment, patients are followed periodically for 1 year.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Mini Mental State Examination score \\> 23\n\nExclusion Criteria:\n\n* Pregnancy\n* Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes\n* Significant liver, renal, or heart disease\n* Diabetes mellitus or other untreated endocrine disease\n* Polycystic ovary syndrome and/or hyperthecosis\n* Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g., Sertoli- Leydig cell tumor)\n* Non-classical adrenal hyperplasia\n* Cushing's syndrome\n* Glucocorticoid resistance\n* Hyperprolactinoma or hypothyroidism\n* Lactose intolerance\n* Alcohol or drug abuse\n* Recent treatment (within 3 months) with anabolic steroids\n* Ongoing anticoagulant therapy\n* Any other circumstance that would preclude study participation, in the opinion of the principal investigator or study physician"}, 'identificationModule': {'nctId': 'NCT00878995', 'briefTitle': 'Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Nutrition and Anabolic Interventions in Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '06-073/10-207'}, 'secondaryIdInfos': [{'id': 'R01CA127971', 'link': 'https://reporter.nih.gov/quickSearch/R01CA127971', 'type': 'NIH'}, {'id': 'CDR0000629579'}, {'id': 'GCRC#724/819'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of Care Therapy + Placebo Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks.', 'interventionNames': ['Drug: Placebo Testosterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Therapy + Testosterone', 'description': 'Patients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks.', 'interventionNames': ['Drug: Testosterone Enanthate 100 MG/ML']}], 'interventions': [{'name': 'Placebo Testosterone', 'type': 'DRUG', 'description': 'Placebo (Saline) Testosterone given IM once per week.', 'armGroupLabels': ['Standard of Care Therapy + Placebo Testosterone']}, {'name': 'Testosterone Enanthate 100 MG/ML', 'type': 'DRUG', 'description': 'Testosterone Enanthate 100mg/ml given once per week IM.', 'armGroupLabels': ['Standard of Care Therapy + Testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555-0361', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Melinda Sheffield-Moore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}