Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
Conditions
Cervical Cancer - Endometrial Cancer - Fallopian Tube Cancer - Ovarian Cancer - Sarcoma - Vaginal Cancer - Vulvar Cancer
Conditions: official terms
Fallopian Tube Neoplasms - Uterine Cervical Neoplasms - Vaginal Neoplasms - Vulvar Neoplasms
Conditions: Keywords
stage IVA cervical cancer, stage IVB cervical cancer, fallopian tube cancer, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer, stage IV endometrial carcinoma, stage IV uterine sarcoma, stage IVA vaginal cancer, stage IVB vaginal cancer, stage IV vulvar cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Primary Purpose: Supportive Care
Intervention
Name: therapeutic nutritional supplementation Type: Dietary Supplement
Name: standard follow-up care Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Centre Oscar Lambret
Lille, France
Status: Recruiting
Contact: Isabelle Rodrigues-Lebrun - 33-32-029-5959
Start Date
June 2008
Sponsors
Centre Oscar Lambret
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page