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

Study Overview
=================
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.

Official Title
-----------------
Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study

Conditions
-----------------
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: therapeutic nutritional supplementation
* Procedure: standard follow-up care


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm I<br>Patients are monitored via standard follow-up assessments every 3 weeks. | Procedure: standard follow-up care<br>* Patients undergo standard monitoring<br>|
| Experimental: Arm II<br>Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks. | Dietary Supplement: therapeutic nutritional supplementation<br>* Patients receive systematic nutritional supplementation<br>Procedure: standard follow-up care<br>* Patients undergo standard monitoring<br>|
| Experimental: Arm III<br>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. | Dietary Supplement: therapeutic nutritional supplementation<br>* Patients receive systematic nutritional supplementation<br>Procedure: standard follow-up care<br>* Patients undergo standard monitoring<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QLQ-C30) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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