Ovarian Cancer Clinical Trial
Official title:
Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II 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.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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