Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT01200602
Status:
TERMINATED
Last Update Posted:
2015-11-25
First Post:
2010-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000855', 'term': 'Anorexia'}, {'id': 'D001836', 'term': 'Body Weight Changes'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019290', 'term': 'Megestrol Acetate'}, {'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008535', 'term': 'Megestrol'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rodriguez.vilmarie@mayo.edu', 'phone': '507-284-2695', 'title': 'Vilmarie Rodriguez, MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'description': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Who Maintain Weight or Experience Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.'}], 'timeFrame': '4 weeks', 'description': 'A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.', 'reportingStatus': 'POSTED', 'populationDescription': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.'}, {'type': 'SECONDARY', 'title': 'BMI Trends', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.'}], 'timeFrame': '4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.'}, {'type': 'SECONDARY', 'title': 'Caloric Intake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.'}], 'timeFrame': '4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.'}, {'type': 'SECONDARY', 'title': 'Weight Maintenance Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.'}], 'timeFrame': '4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.'}, {'type': 'SECONDARY', 'title': 'Toxicity Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.'}], 'timeFrame': '4 weeks', 'description': 'Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0', 'reportingStatus': 'POSTED', 'populationDescription': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.'}, {'id': 'FG001', 'title': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'One patient was accrued between March 2, 2011 and January 10, 2012. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.'}, {'id': 'BG001', 'title': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'paramType': 'MEAN', 'description': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Female'}, {'title': 'Male'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'paramType': 'NUMBER', 'description': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'The study closed due to slow accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2010-09-10', 'resultsFirstSubmitDate': '2013-03-29', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2015-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-29', 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Who Maintain Weight or Experience Weight Gain', 'timeFrame': '4 weeks', 'description': 'A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.'}], 'secondaryOutcomes': [{'measure': 'BMI Trends', 'timeFrame': '4 weeks'}, {'measure': 'Caloric Intake', 'timeFrame': '4 weeks'}, {'measure': 'Weight Maintenance Over Time', 'timeFrame': '4 weeks'}, {'measure': 'Toxicity Profile', 'timeFrame': '4 weeks', 'description': 'Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anorexia', 'Weight Changes']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.', 'detailedDescription': 'PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.\n\nSECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas)\n* ≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy\n* Negative pregnancy test done =\\< 7 days prior to registration for women of childbearing potential only\n\nExclusion Criteria:\n\n* Receiving tube feedings or parenteral nutrition\n* Evidence of ascites\n* Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol)\n* Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (\\> 5 episodes/week)\n* History of unresectable brain tumor or cancer metastatic to the brain\n* History of thromboembolic disease\n* Insulin-requiring diabetes\n* Congestive heart failure and/or uncontrolled hypertension\n* Anticoagulation\n* Previous history of thrombosis (personal and immediate family)\n* Concurrent corticosteroid therapy (except as an antiemetic)'}, 'identificationModule': {'nctId': 'NCT01200602', 'briefTitle': 'Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia', 'orgStudyIdInfo': {'id': 'MC0896'}, 'secondaryIdInfos': [{'id': 'NCI-2010-01938', 'type': 'REGISTRY', 'domain': 'NCI-CTRP'}, {'id': '09-007533', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}, {'id': 'MC0896', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.', 'interventionNames': ['Drug: megestrol acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'Patients have clinical observation for weight loss and gain for 4 weeks.', 'interventionNames': ['Other: clinical observation']}], 'interventions': [{'name': 'megestrol acetate', 'type': 'DRUG', 'otherNames': ['BDH 1298', 'Maygace', 'Megace', 'Megestil', 'Niagestin', 'Pallace'], 'description': 'Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day', 'armGroupLabels': ['Arm A']}, {'name': 'clinical observation', 'type': 'OTHER', 'otherNames': ['observation'], 'description': 'No treatment is given.', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Vilmarie Rodriguez, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}