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

Primary Purpose

Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
therapeutic nutritional supplementation
standard follow-up care
Sponsored by
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervical Cancer focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Oscar LambretRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm III

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Quality of life (QLQ-C30)

Secondary Outcome Measures

Full Information

First Posted
May 19, 2009
Last Updated
July 28, 2009
Sponsor
Centre Oscar Lambret
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1. Study Identification

Unique Protocol Identification Number
NCT00905658
Brief Title
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
Official Title
Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Oscar Lambret

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
No Intervention
Arm Description
Patients are monitored via standard follow-up assessments every 3 weeks.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
Arm Title
Arm III
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
therapeutic nutritional supplementation
Intervention Description
Patients receive systematic nutritional supplementation
Intervention Type
Procedure
Intervention Name(s)
standard follow-up care
Intervention Description
Patients undergo standard monitoring
Primary Outcome Measure Information:
Title
Quality of life (QLQ-C30)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Rodrigues-Lebrun
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Rodrigues-Lebrun
Phone
33-32-029-5959

12. IPD Sharing Statement

Learn more about this trial

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

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