Last updated on July 2009

Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer


Brief description of study

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.

Detailed Study Description

OBJECTIVES: Primary - Measure quality of life (QLQ-C30) at week 18 in patients with metastatic gynecological cancer receiving systematic nutritional supplements during first-line chemotherapy. Secondary - Study the maintenance or improvement of intake and nutritional status. - Study the quality of life during chemotherapy. - Evaluate tolerance and compliance to treatment with nutritional supplements. - Evaluate the feasibility of and the tolerance to chemotherapy. - Measure the overall survival over 18 weeks. - Analyze the cost-effectiveness of different strategies of nutritional care. OUTLINE: Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients are monitored via standard follow-up assessments every 3 weeks. - Arm II: Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks. - 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.

Clinical Study Identifier: NCT00905658

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