Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT00905658
Status:
UNKNOWN
Last Update Posted:
2009-07-29
First Post:
2009-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
Sponsor:
Centre Oscar Lambret
Organization:
Study Overview
Official Title:
Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: