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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma Vaginal Cancer Vulvar Cancer

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Study Groups

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Arm I

Patients are monitored via standard follow-up assessments every 3 weeks.

Group Type NO_INTERVENTION

standard follow-up care

Intervention Type PROCEDURE

Patients undergo standard monitoring

Arm II

Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.

Group Type EXPERIMENTAL

therapeutic nutritional supplementation

Intervention Type DIETARY_SUPPLEMENT

Patients receive systematic nutritional supplementation

standard follow-up care

Intervention Type PROCEDURE

Patients undergo standard monitoring

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.

Group Type EXPERIMENTAL

therapeutic nutritional supplementation

Intervention Type DIETARY_SUPPLEMENT

Patients receive systematic nutritional supplementation

standard follow-up care

Intervention Type PROCEDURE

Patients undergo standard monitoring

Interventions

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therapeutic nutritional supplementation

Patients receive systematic nutritional supplementation

Intervention Type DIETARY_SUPPLEMENT

standard follow-up care

Patients undergo standard monitoring

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No