Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT00091169
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2004-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Levocarnitine in Treating Fatigue in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'C536778', 'term': 'Systemic carnitine deficiency'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '617-632-3012', 'title': 'Study statistician', 'organization': 'ECOG-ACRIN Statistical Office'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Assessed every 4 weeks while on treatment and for 30 days after the end of treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Levocarnitine', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally', 'otherNumAtRisk': 166, 'otherNumAffected': 10, 'seriousNumAtRisk': 166, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally', 'otherNumAtRisk': 171, 'otherNumAffected': 9, 'seriousNumAtRisk': 171, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Platelets decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Pruritus/itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Death - disease progression NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Diarrhea w/o prior colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Infection w/ unk ANC urinary tract NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Abdomen, pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 3.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocarnitine', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.\n\nlevocarnitine: Given orally'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.96', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '-0.60'}, {'value': '-1.11', 'groupId': 'OG001', 'lowerLimit': '-1.44', 'upperLimit': '-0.78'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients'}, {'type': 'SECONDARY', 'title': 'Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocarnitine', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.\n\nlevocarnitine: Given orally'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '5.36', 'groupId': 'OG000', 'lowerLimit': '3.71', 'upperLimit': '7.01'}, {'value': '4.04', 'groupId': 'OG001', 'lowerLimit': '2.39', 'upperLimit': '5.69'}]}]}], 'analyses': [{'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who reported FACIT-F score at both baseline and 4 weeks'}, {'type': 'SECONDARY', 'title': 'Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocarnitine', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.\n\nlevocarnitine: Given orally'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.05', 'groupId': 'OG000', 'lowerLimit': '-4.45', 'upperLimit': '-1.65'}, {'value': '-2.91', 'groupId': 'OG001', 'lowerLimit': '-4.21', 'upperLimit': '-1.61'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who reported CES-D score at both baseline and 4 weeks'}, {'type': 'SECONDARY', 'title': 'Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levocarnitine', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.\n\nlevocarnitine: Given orally'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000', 'lowerLimit': '-0.525', 'upperLimit': '0.145'}, {'value': '-0.08', 'groupId': 'OG001', 'lowerLimit': '-0.434', 'upperLimit': '0.274'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who reported BPI score at both baseline and 4 weeks'}, {'type': 'SECONDARY', 'title': 'Prevalence of Carnitine Deficiency at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.\n\nlevocarnitine: Given orally'}, {'id': 'OG001', 'title': 'Arm II', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0.113', 'groupId': 'OG000', 'lowerLimit': '0.064', 'upperLimit': '0.179'}, {'value': '0.333', 'groupId': 'OG001', 'lowerLimit': '0.254', 'upperLimit': '0.421'}]}]}], 'analyses': [{'pValue': '0.00001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'assessed at 4 weeks after randomization', 'description': 'Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine \\> 0.4 μmol/L or free carnitine \\< 35 μmol/L for males and \\< 25 μmol/L for females.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who had carnitine data at 4 weeks'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Stable or Improving Performance Status at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.\n\nlevocarnitine: Given orally'}, {'id': 'OG001', 'title': 'Arm II', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0.806', 'groupId': 'OG000', 'lowerLimit': '0.735', 'upperLimit': '0.865'}, {'value': '0.875', 'groupId': 'OG001', 'lowerLimit': '0.814', 'upperLimit': '0.922'}]}]}], 'analyses': [{'pValue': '0.677', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who had performance status data at baseline and 4 weeks'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levocarnitine', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.\n\nlevocarnitine: Given orally'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.\n\nplacebo: Given orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '187'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Not start protocol therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}], 'recruitmentDetails': 'This study was activated on 11/3/2005, accrued its first patient 12/16/2005, suspended on 5/4/2006 after reaching its original accrual goal (160 eligible patients), reactivated on 9/6/2006 after the accrual target amendment (286 eligible patients) was approved, and closed on 1/23/2007 with a total accrual of 376 patients.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '376', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Levocarnitine', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.\n\nlevocarnitine: Given orally'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.\n\nplacebo: Given orally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '91'}, {'value': '62', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '88'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '29', 'upperLimit': '91'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized patients'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2004-09-07', 'resultsFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2004-09-07', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-03', 'studyFirstPostDateStruct': {'date': '2004-09-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.'}], 'secondaryOutcomes': [{'measure': 'Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline.'}, {'measure': 'Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline.'}, {'measure': 'Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline.'}, {'measure': 'Prevalence of Carnitine Deficiency at 4 Weeks', 'timeFrame': 'assessed at 4 weeks after randomization', 'description': 'Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine \\> 0.4 μmol/L or free carnitine \\< 35 μmol/L for males and \\< 25 μmol/L for females.'}, {'measure': 'Proportion of Patients With Stable or Improving Performance Status at 4 Weeks', 'timeFrame': 'assessed at baseline and 4 weeks after randomization', 'description': 'Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fatigue', 'unspecified adult solid tumor, protocol specific', 'levocarnitine', 'depression', 'pain', 'carnitine deficiency'], 'conditions': ['Fatigue', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '22987089', 'type': 'RESULT', 'citation': 'Cruciani RA, Zhang JJ, Manola J, Cella D, Ansari B, Fisch MJ. L-carnitine supplementation for the management of fatigue in patients with cancer: an eastern cooperative oncology group phase III, randomized, double-blind, placebo-controlled trial. J Clin Oncol. 2012 Nov 1;30(31):3864-9. doi: 10.1200/JCO.2011.40.2180. Epub 2012 Sep 17.'}, {'type': 'RESULT', 'citation': 'Rich TA, Manola J, Cella D, et al.: An evaluation of serum cytokine levels and fatigue and depression in ECOG E4Z02. [Abstract] J Clin Oncol 29 (Suppl 15): A-9046, 2011.'}, {'type': 'RESULT', 'citation': 'Rich TA, Fisch MJ, Manola J, et al.: Analysis of cytokines in ECOG E4Z02: A phase III randomized study of l-carnitine supplementation for fatigue in patients with cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-9635, 2009.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Levocarnitine may help improve energy levels in cancer patients.\n\nPURPOSE: This randomized phase III trial is studying how well levocarnitine works compared to a placebo in treating fatigue in cancer patients.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary Objective:\n\n* Compare the efficacy of levocarnitine (L-carnitine) supplementation vs placebo for the management of fatigue in patients with cancer.\n\nSecondary Objectives:\n\n* Assess the effect of levocarnitine on pain, depression and performance status at 4 and 8 weeks of follow-up.\n* Determine the prevalence of serum carnitine deficiency in patients treated with these regimens.\n* Explore the association between carnitine deficiency and fatigue.\n* Present the toxicity profiles of all patients.\n\nCorrelative Objective:\n\n* Measure serum levels of the pro-inflammatory cytokines and growth factors and correlate with fatigue and other onco-behavioral symptoms.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, ECOG performance status (0-1 vs 2-3), and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms in a 1:1 ratio.\n\n* Arm I (levocarnitine): Patients receive oral levocarnitine (L-carnitine) twice daily (2000 mg/day) on weeks 1-4.\n* Arm II (placebo): Patients receive oral placebo twice daily (2000 mg/day) on weeks 1-4.\n\nThe dose was titrated over a 2-day period (i.e. two 500 mg doses the first day and two 1000 mg doses the second day) to avoid gastrointestinal side effects. Patients then continued to receive two daily doses of 1000 mg on days 3 to 28.\n\nAfter week 4, all patients (on both arms) receive open-label oral L-carnitine twice daily on weeks 5-8 (extension phase) administered in the same fashion as during the first 4 weeks. For patients who had received a dose modification during weeks 1 to 4, they received the same reduced dose during the extension phase (without titration)\n\nFatigue, pain, and depression are assessed at baseline and then at weeks 4 and 8.\n\nPROJECTED ACCRUAL: A total of 352 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of an invasive malignant disorder\n* Moderate to severe fatigue within the past 4 weeks, defined as a score of ≥ 2 (on a scale of 0-4) on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) question "I feel fatigued"\n* Age 18 and over\n* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-3\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 3 months after study participation\n\nExclusion Criteria:\n\n* Brain metastases\n* Hemoglobin \\< 9 g/dL, taken \\<=4 weeks prior to registration\n* Severe, uncontrolled liver disease\n* Evidence of severely compromised renal function including any 1 of the following:\n\n * Renal failure\n * End stage renal disease\n * Ongoing renal dialysis\n* Severe, uncontrolled cardiovascular disease\n* Severe, uncontrolled pulmonary disease\n* Pregnant or nursing\n* History of seizures\n* Known sensitivity to carnitine\n* Delirium\n* Nausea \\> grade 1\n* Taking any form of levocarnitine (L-carnitine) supplementation or nutritional supplements containing carnitine within 2 months prior to registration'}, 'identificationModule': {'nctId': 'NCT00091169', 'briefTitle': 'Levocarnitine in Treating Fatigue in Cancer Patients', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Phase III Randomized Placebo-Controlled Trial to Determine Efficacy of Levocarnitine for Fatigue in Patients With Cancer', 'orgStudyIdInfo': {'id': 'E4Z02'}, 'secondaryIdInfos': [{'id': 'E4Z02', 'type': 'OTHER', 'domain': 'Eastern Cooperative Oncology Group'}, {'id': 'U10CA023318', 'link': 'https://reporter.nih.gov/quickSearch/U10CA023318', 'type': 'NIH'}, {'id': 'CDR0000384087', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.', 'interventionNames': ['Dietary Supplement: levocarnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II', 'description': 'Patients receive oral placebo twice daily on weeks 1-4.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'levocarnitine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given orally', 'armGroupLabels': ['Arm I']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given orally', 'armGroupLabels': ['Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - 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