NCT00905658

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Cancer
• Endometrial Cancer
• Fallopian Tube Cancer
• Ovarian Cancer
• Sarcoma
• Vaginal Cancer
• Vulvar Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	therapeutic nutritional supplementation	Patients receive systematic nutritional supplementation
PROCEDURE	standard follow-up care	Patients undergo standard monitoring

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-11-01
• First posted: 2009-05-20
• Last updated: 2009-07-29

Locations

1 site across 1 country: France