Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-27 @ 7:59 PM
Study NCT ID:
NCT01506466
Status:
COMPLETED
Last Update Posted:
2015-07-24
First Post:
2012-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Variation During Chemotherapy in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-23', 'studyFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in body composition', 'timeFrame': 'within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in energy balance', 'timeFrame': 'within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.', 'description': 'resting energy expenditure, physical activity, food records.'}, {'measure': 'Change from baseline in muscle strength', 'timeFrame': 'within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.'}, {'measure': 'Change from baseline in biological factors (hormonal, inflammatory, lipid, growth factors)', 'timeFrame': 'within 2 weeks before chemotherapy; 1month after the last chemotherapy; and 6 months later.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chemotherapy', 'metabolism', 'weight', 'body composition'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.\n\nThus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* menopausal women\n* breast cancer\n* patients requiring chemotherapy treatment\n* WHO performance status 0-2\n\nExclusion Criteria:\n\n* diabetics\n* patients with metastases\n* other cancer'}, 'identificationModule': {'nctId': 'NCT01506466', 'briefTitle': 'Weight Variation During Chemotherapy in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Jean Perrin'}, 'officialTitle': 'Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients', 'orgStudyIdInfo': {'id': '2011-A00206-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'additional examinations/measurements', 'interventionNames': ['Other: blood test/ additional measurement']}], 'interventions': [{'name': 'blood test/ additional measurement', 'type': 'OTHER', 'description': 'blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation', 'armGroupLabels': ['additional examinations/measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Xavier DURANDO, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Jean Perrin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Jean Perrin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}