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| ID | Type | Description | Link |
|---|---|---|---|
| COL-NUTRYS | |||
| COL-2007-06 | |||
| COL-IDRCB-2007-A00454-49 | |||
| INCA-RECF0634 |
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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.
PURPOSE: 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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | No Intervention | Patients are monitored via standard follow-up assessments every 3 weeks. |
|
| Arm II | Experimental | Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks. |
|
| Arm III | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic nutritional supplementation | Dietary Supplement | Patients receive systematic nutritional supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (QLQ-C30) |
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DISEASE CHARACTERISTICS:
Histologically confirmed gynecological cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Rodrigues-Lebrun | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Recruiting | Lille | 59020 | France |
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| standard follow-up care | Procedure | Patients undergo standard monitoring |
|
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D012509 | Sarcoma |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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