Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-24 @ 7:45 PM
Study NCT ID:
NCT02491632
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-28
First Post:
2015-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C059464', 'term': 'auricularum'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}, {'id': 'C004180', 'term': 'dexamethasone 21-phosphate'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'syennu@mdanderson.org', 'phone': '(713) 792-3938', 'title': 'Sriram Yennu,MD- Professor, Palliative Care Med', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Day 29', 'eventGroups': [{'id': 'EG000', 'title': 'Physical Exercise + Low Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Physical Exercise + High Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Eye Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thromboembolic Event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Exercise + Low Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days'}, {'id': 'OG001', 'title': 'Physical Exercise + High Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days'}], 'classes': [{'title': 'Change between Baseline and Day 8', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '19'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '18'}]}]}, {'title': 'Change between Baseline and Day 29', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '16'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '20'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'groupDescription': 'Change between Baseline and Day 8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG000'], 'groupDescription': 'Change between Baseline and Day 29', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG001'], 'groupDescription': 'Change between Baseline and Day 8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG001'], 'groupDescription': 'Change between Baseline and Day 29', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, day 8, day 29', 'description': 'FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level. We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Exercise + Low Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days'}, {'id': 'OG001', 'title': 'Physical Exercise + High Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days'}], 'classes': [{'title': 'Change between Baseline and Day 8', 'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '0'}, {'value': '-4', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '0'}]}]}, {'title': 'Change between Baseline and Day 29', 'categories': [{'measurements': [{'value': '-9', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '0'}, {'value': '-7', 'groupId': 'OG001', 'lowerLimit': '-9', 'upperLimit': '-1'}]}]}], 'analyses': [{'pValue': '=.003', 'groupIds': ['OG000'], 'groupDescription': 'Change between Baseline and Day 8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG000'], 'groupDescription': 'Change between Baseline and Day 29', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG001'], 'groupDescription': 'Change between Baseline and Day 8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG001'], 'groupDescription': 'Change between Baseline and Day 29', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, day 8, day 29', 'description': "The PROMIS-F (Patient Reported Outcome Measurement Information System-Fatigue) short form was used to measure the experience of fatigue in patients' daily activities over the past week. It consists of 7 items with response options on a 5-point Likert scale, ranging from 1 (never) to 5 (always). We measured the change in PROMIS-F score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test. The total score is used in the analysis and is obtained by summing keyed scores of all items. Scores can range from 7 to 35, with higher scores indicating greater fatigue.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Exercise + Low Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days'}, {'id': 'OG001', 'title': 'Physical Exercise + High Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days'}], 'classes': [{'title': 'Change between Baseline and Day 8', 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '0'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '0'}]}]}, {'title': 'Change between Baseline and Day 29', 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '0'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '-1'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'groupDescription': 'Change between Baseline and Day 8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.065', 'groupIds': ['OG000'], 'groupDescription': 'Change between Baseline and Day 29', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG001'], 'groupDescription': 'Change between Baseline and Day 8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '<.001', 'groupIds': ['OG001'], 'groupDescription': 'Change between Baseline and Day 29', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, day 8, day 29', 'description': 'ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of wellbeing. We measured the change in ESAS fatigue score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test. Total ESAS fatigue score ranges from 0-10, with a higher score indicating higher fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Physical Exercise + Low Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days'}, {'id': 'OG001', 'title': 'Physical Exercise + High Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days'}], 'classes': [{'title': 'Change between Baseline and Day 8', 'categories': [{'measurements': [{'value': '-9', 'groupId': 'OG000', 'lowerLimit': '-16', 'upperLimit': '-3'}, {'value': '-5', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '3'}]}]}, {'title': 'Change between Baseline and Day 29', 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '-1'}, {'value': '-4.5', 'groupId': 'OG001', 'lowerLimit': '-15.5', 'upperLimit': '6.5'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000'], 'groupDescription': 'Change between Baseline and Day 8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '=.30', 'groupIds': ['OG000'], 'groupDescription': 'Change between Baseline and Day 29', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '=.19', 'groupIds': ['OG001'], 'groupDescription': 'Change between Baseline and Day 8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '=.27', 'groupIds': ['OG001'], 'groupDescription': 'Change between Baseline and Day 29', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, day 8, day 29', 'description': 'The MFSI-SF is a 30-item scale used to assess the multidimensional nature of fatigue. Responses are selected using a 5-point scale, ranging from 0 (not at all) to 4 (extremely fatigue). It consists of 5 subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue and vigor. The MFSI-SF total score is the sum of the general fatigue, physical fatigue, emotional fatigue and mental fatigue subscale score and subtracting vigor subscale score. Thus MFSI-SF total score ranges from 24-96, with a higher score indicating a higher fatigue level. We measured the change in MFSI-SF total score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Physical Exercise + Low Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days'}, {'id': 'FG001', 'title': 'Physical Exercise + High Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Patients were recruited from MD Anderson Cancer Center outpatients clinic for supportive are who has a diagnosis of advanced cancer with average intensity of fatigue of \\>=4/10 on the ESAS scale in the previous 24 hours and presence of fatigue for at least 2 weeks.', 'preAssignmentDetails': 'A total of 90 patients were enrolled for this study. Of them 7 withdrew their consent, Doctor did not allow Dexamethasone for 3 cases, 2 had disease progression, and for 2 cases, their oncologist did not approve it. Thus a total of 76 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Physical Exercise + Low Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 4mg of Dexamethasone orally twice daily for 7 days'}, {'id': 'BG001', 'title': 'Physical Exercise + High Dose Dexamethasone', 'description': 'Received stabdardizex Physical activity for 4 weeks and 8mg of Dexamethasone orally twice daily for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '68'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '63'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '54', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', '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': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cancer Diagnosis', 'classes': [{'categories': [{'title': 'Breast', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Lung', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Gastrointestinal', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Genitourinary', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Assessment', 'classes': [{'title': 'Edmonton Symptom Assessment System (ESAS) Fatigue Score', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '7.5'}]}]}, {'title': 'Hospital Anxiety and Depression Scale (HADS) Anxiety', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '8'}]}]}, {'title': 'Hospital Anxiety and Depression Scale (HADS) Depression', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '8'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '8'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '8'}]}]}, {'title': 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '29.3'}, {'value': '20', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '31'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'description': 'Edmonton Symptom Assessment System (ESAS) Fatigue score ranges from 0-10, higher score indicates higher fatigue. Hospital Anxiety and Depression Scale (HADS) Anxiety scores ranges from 0-21, higher score indicates higher anxiety. Hospital Anxiety and Depression Scale (HADS) Depression score ranges from 0-21, higher score indicates higher depression. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale score ranges from 0-52, lower score indicates higher fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Participants who completed the intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-17', 'size': 1110877, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-18T11:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2015-07-03', 'resultsFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2015-07-03', 'lastUpdatePostDateStruct': {'date': '2025-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-08-25', 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29', 'timeFrame': 'Baseline, day 8, day 29', 'description': 'FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level. We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.'}], 'secondaryOutcomes': [{'measure': 'Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total', 'timeFrame': 'Baseline, day 8, day 29', 'description': "The PROMIS-F (Patient Reported Outcome Measurement Information System-Fatigue) short form was used to measure the experience of fatigue in patients' daily activities over the past week. It consists of 7 items with response options on a 5-point Likert scale, ranging from 1 (never) to 5 (always). We measured the change in PROMIS-F score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test. The total score is used in the analysis and is obtained by summing keyed scores of all items. Scores can range from 7 to 35, with higher scores indicating greater fatigue."}, {'measure': 'Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue', 'timeFrame': 'Baseline, day 8, day 29', 'description': 'ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of wellbeing. We measured the change in ESAS fatigue score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test. Total ESAS fatigue score ranges from 0-10, with a higher score indicating higher fatigue.'}, {'measure': 'Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score', 'timeFrame': 'Baseline, day 8, day 29', 'description': 'The MFSI-SF is a 30-item scale used to assess the multidimensional nature of fatigue. Responses are selected using a 5-point scale, ranging from 0 (not at all) to 4 (extremely fatigue). It consists of 5 subscales: general fatigue, physical fatigue, emotional fatigue, mental fatigue and vigor. The MFSI-SF total score is the sum of the general fatigue, physical fatigue, emotional fatigue and mental fatigue subscale score and subtracting vigor subscale score. Thus MFSI-SF total score ranges from 24-96, with a higher score indicating a higher fatigue level. We measured the change in MFSI-SF total score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Neoplasm', 'Fatigue', 'Metastatic Malignant Neoplasm', 'Recurrent Malignant Neoplasm', 'Refractory Malignant Neoplasm']}, 'referencesModule': {'references': [{'pmid': '34965510', 'type': 'DERIVED', 'citation': 'Yennurajalingam S, Valero V, Lu Z, Liu DD, Busaidy NL, Reuben JM, Diaz Fleming C, Williams JL, Hess KR, Basen-Engquist K, Bruera E. Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial. J Natl Compr Canc Netw. 2021 Dec 29;20(3):235-243. doi: 10.6004/jnccn.2021.7066.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\n1\\. To determine the feasibility, adherence, and satisfaction with physical activity (PA) plus dexamethasone (PA+ DEX).\n\nSECONDARY OBJECTIVES:\n\nI. To explore the preliminary efficacy of PA+ Hi Dex group (PA for 4 weeks plus high dose dexamethasone for 1 week) and PA + Lo Dex groups (PA for 4 weeks plus low dose dexamethasone for 1 week) on cancer-related fatigue (CRF) as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at the end of one week.\n\nII. To explore the effects of PA+ Hi Dex on the various dimensions of CRF (Patient-Reported Outcomes Measurement Information System-Fatigue \\[PROMIS-F\\]), i.e., affective/emotional (Hospital Anxiety Depression Scale \\[HADS\\]); physical/behavioral (the Multidimensional Fatigue Symptom Inventory-Short Form \\[MFSI-SF\\], Pittsburg Sleep Quality Index), physical activity and function (30 second sit-to stand test, six minute walk test) before and after treatment.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I: Patients receive high-dose dexamethasone orally (PO) twice daily (BID) for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.\n\nARM II: Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.\n\nAfter completion of study, patients are followed up at day 29 and again after 1 month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue \\>= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)\n* The presence of fatigue for at least 2 weeks\n* Normal cognition\n* Hemoglobin \\> 8 g/L within 1 week of enrollment in the study\n* A life expectancy of \\>= 4 months\n* No evidence of significant anxiety or depression as determined by a total HADS scores of \\< 21\n* Definition of advanced cancer includes those patients who have metastatic or refractory disease according to their treating oncologist\n* Patients must be able to understand, read, write, and speak English or Spanish\n\nExclusion Criteria:\n\n* Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician\n* Reports a fall in the past 30 days\n* Uncontrolled diabetes mellitus as defined by a random blood sugar of \\> 200 mg/dl not being monitored by their primary care physician\n* Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials\n* Will exclude patients with current, active peptic ulcer disease\n* Neutropenia as defined by an absolute neutrophil count (ANC) of \\< 1000 cells/mm\n* Regular participation in moderate- or vigorous-intensity physical activity for \\>= 30 minutes at least 5 times a week and strength training for \\>= 2 days\n* Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease'}, 'identificationModule': {'nctId': 'NCT02491632', 'briefTitle': 'Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Effects of Physical Activity Plus Short Course of Dexamethasone for Cancer-Related Fatigue in Advanced Cancer', 'orgStudyIdInfo': {'id': '2014-0436'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01320', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2014-0436', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (high-dose dexamethasone, physical activity)', 'description': 'Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.', 'interventionNames': ['Drug: Dexamethasone', 'Behavioral: Exercise Intervention', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (low dose dexamethasone, physical activity)', 'description': 'Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.', 'interventionNames': ['Drug: Dexamethasone', 'Behavioral: Exercise Intervention', 'Other: Laboratory Biomarker Analysis', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Aacidexam', 'Adexone', 'Aknichthol Dexa', 'Alba-Dex', 'Alin', 'Alin Depot', 'Alin Oftalmico', 'Amplidermis', 'Anemul mono', 'Auricularum', 'Auxiloson', 'Baycuten', 'Baycuten N', 'Cortidexason', 'Cortisumman', 'Decacort', 'Decadrol', 'Decadron', 'Decalix', 'Decameth', 'Decasone R.p.', 'Dectancyl', 'Dekacort', 'Deltafluorene', 'Deronil', 'Desamethasone', 'Desameton', 'Dexa-Mamallet', 'Dexa-Rhinosan', 'Dexa-Scheroson', 'Dexa-sine', 'Dexacortal', 'Dexacortin', 'Dexafarma', 'Dexafluorene', 'Dexalocal', 'Dexamecortin', 'Dexameth', 'Dexamethasonum', 'Dexamonozon', 'Dexapos', 'Dexinoral', 'Dexone', 'Dinormon', 'Fluorodelta', 'Fortecortin', 'Gammacorten', 'Hexadecadrol', 'Hexadrol', 'Lokalison-F', 'Loverine', 'Methylfluorprednisolone', 'Millicorten', 'Mymethasone', 'Orgadrone', 'Spersadex', 'Visumetazone'], 'description': 'Given PO', 'armGroupLabels': ['Arm I (high-dose dexamethasone, physical activity)', 'Arm II (low dose dexamethasone, physical activity)']}, {'name': 'Exercise Intervention', 'type': 'BEHAVIORAL', 'description': 'Complete a graded resistance exercise program and a walking regimen', 'armGroupLabels': ['Arm I (high-dose dexamethasone, physical activity)', 'Arm II (low dose dexamethasone, physical activity)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (high-dose dexamethasone, physical activity)', 'Arm II (low dose dexamethasone, physical activity)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (high-dose dexamethasone, physical activity)', 'Arm II (low dose dexamethasone, physical activity)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (high-dose dexamethasone, physical activity)', 'Arm II (low dose dexamethasone, physical activity)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Sriram Yennu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}