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

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed gynecological cancer

  • Currently receiving first-line chemotherapy for metastatic disease

PATIENT CHARACTERISTICS:

• WHO performance status (PS) 0-2 or Karnofsky PS 70-100%
• Not pregnant or nursing
• Intake < 75% of theoretical need
• Weight loss ≥ 5% within the past 6 months
• No patients with dementia or altered mental status
• No psychological, familial, social, or geographic situations that preclude clinical follow up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent radiotherapy