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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905658
First Posted: May 20, 2009
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma Vaginal Cancer Vulvar Cancer Dietary Supplement: therapeutic nutritional supplementation Procedure: standard follow-up care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Quality of life (QLQ-C30)

Estimated Enrollment: 120
Study Start Date: June 2008
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: therapeutic nutritional supplementation
Patients receive systematic nutritional supplementation
Procedure: standard follow-up care
Patients undergo standard monitoring
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.
Dietary Supplement: therapeutic nutritional supplementation
Patients receive systematic nutritional supplementation
Procedure: standard follow-up care
Patients undergo standard monitoring

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905658


Locations
France
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Isabelle Rodrigues-Lebrun    33-32-029-5959      
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Isabelle Rodrigues-Lebrun Centre Oscar Lambret
  More Information

ClinicalTrials.gov Identifier: NCT00905658     History of Changes
Other Study ID Numbers: CDR0000633553
COL-NUTRYS
COL-2007-06
COL-IDRCB-2007-A00454-49
INCA-RECF0634
First Submitted: May 19, 2009
First Posted: May 20, 2009
Last Update Posted: July 29, 2009
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Sarcoma
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Fallopian Tube Diseases
Adnexal Diseases
Vulvar Diseases
Vaginal Diseases