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

July 28, 2009 updated by: Centre Oscar Lambret

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
          • Isabelle Rodrigues-Lebrun
          • Phone Number: 33-32-029-5959

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Patients are monitored via standard follow-up assessments every 3 weeks.
Procedure: standard follow-up care
Patients undergo standard monitoring
Experimental: Arm II
Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
Procedure: standard follow-up care
Patients undergo standard monitoring
Dietary supplement: therapeutic nutritional supplementation
Patients receive systematic nutritional supplementation
Experimental: 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.
Procedure: standard follow-up care
Patients undergo standard monitoring
Dietary supplement: therapeutic nutritional supplementation
Patients receive systematic nutritional supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life (QLQ-C30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Isabelle Rodrigues-Lebrun, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

July 29, 2009

Last Update Submitted That Met QC Criteria

July 28, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000633553
  • COL-NUTRYS
  • COL-2007-06
  • COL-IDRCB-2007-A00454-49
  • INCA-RECF0634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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