Spots Global Cancer Trial Database for Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer

Study Description

Brief Summary: 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 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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