Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT00905658
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:
NCT00905658
Study Brief:
Protocol Section:
NCT00905658