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

Phase 2

• Conditions: Cervical Cancer; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Sarcoma; Vaginal Cancer; Vulvar Cancer
• Interventions: Procedure: standard follow-up care; Dietary Supplement: therapeutic nutritional supplementation

• Registration Number: NCT00905658
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-28
• Last Update Posted: 2009-07-29
• Primary Completion: 2009-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	standard follow-up care	Patients are monitored via standard follow-up assessments every 3 weeks.
Arm II	therapeutic nutritional supplementation	Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
Arm II	standard follow-up care	Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
Arm III	therapeutic nutritional supplementation	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.
Arm III	standard follow-up care	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.

Primary Outcome Measures

Name	Time	Method
Quality of life (QLQ-C30)

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France