Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT00905658
Status:
UNKNOWN
Last Update Posted:
2009-07-29
First Post:
2009-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D014625', 'term': 'Vaginal Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2009-07-28', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life (QLQ-C30)'}]}, 'conditionsModule': {'keywords': ['stage IVA cervical cancer', 'stage IVB cervical cancer', 'fallopian tube cancer', 'stage IV ovarian epithelial cancer', 'stage IV ovarian germ cell tumor', 'ovarian sarcoma', 'ovarian stromal cancer', 'stage IV endometrial carcinoma', 'stage IV uterine sarcoma', 'stage IVA vaginal cancer', 'stage IVB vaginal cancer', 'stage IV vulvar cancer'], 'conditions': ['Cervical Cancer', 'Endometrial Cancer', 'Fallopian Tube Cancer', 'Ovarian Cancer', 'Sarcoma', 'Vaginal Cancer', 'Vulvar Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment.\n\nPURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Measure quality of life (QLQ-C30) at week 18 in patients with metastatic gynecological cancer receiving systematic nutritional supplements during first-line chemotherapy.\n\nSecondary\n\n* Study the maintenance or improvement of intake and nutritional status.\n* Study the quality of life during chemotherapy.\n* Evaluate tolerance and compliance to treatment with nutritional supplements.\n* Evaluate the feasibility of and the tolerance to chemotherapy.\n* Measure the overall survival over 18 weeks.\n* Analyze the cost-effectiveness of different strategies of nutritional care.\n\nOUTLINE: Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I: Patients are monitored via standard follow-up assessments every 3 weeks.\n* Arm II: Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.\n* Arm III: Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks with additional biweekly assessments completed at home by a service provider.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed gynecological cancer\n\n * Currently receiving first-line chemotherapy for metastatic disease\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status (PS) 0-2 or Karnofsky PS 70-100%\n* Not pregnant or nursing\n* Intake \\< 75% of theoretical need\n* Weight loss ≥ 5% within the past 6 months\n* No patients with dementia or altered mental status\n* No psychological, familial, social, or geographic situations that preclude clinical follow up\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No concurrent radiotherapy'}, 'identificationModule': {'nctId': 'NCT00905658', 'briefTitle': 'Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study', 'orgStudyIdInfo': {'id': 'CDR0000633553'}, 'secondaryIdInfos': [{'id': 'COL-NUTRYS'}, {'id': 'COL-2007-06'}, {'id': 'COL-IDRCB-2007-A00454-49'}, {'id': 'INCA-RECF0634'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm I', 'description': 'Patients are monitored via standard follow-up assessments every 3 weeks.', 'interventionNames': ['Procedure: standard follow-up care']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.', 'interventionNames': ['Dietary Supplement: therapeutic nutritional supplementation', 'Procedure: standard follow-up care']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III', 'description': 'Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks with additional biweekly assessments completed at home by a service provider.', 'interventionNames': ['Dietary Supplement: therapeutic nutritional supplementation', 'Procedure: standard follow-up care']}], 'interventions': [{'name': 'therapeutic nutritional supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients receive systematic nutritional supplementation', 'armGroupLabels': ['Arm II', 'Arm III']}, {'name': 'standard follow-up care', 'type': 'PROCEDURE', 'description': 'Patients undergo standard monitoring', 'armGroupLabels': ['Arm I', 'Arm II', 'Arm III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle Rodrigues-Lebrun', 'role': 'CONTACT', 'phone': '33-32-029-5959'}], 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Isabelle Rodrigues-Lebrun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}}}}