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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)
May 19, 2009
May 20, 2009
July 29, 2009
June 2008
November 2009   (Final data collection date for primary outcome measure)
Quality of life (QLQ-C30)
Same as current
Complete list of historical versions of study NCT00905658 on ClinicalTrials.gov Archive Site
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Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
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.

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.
Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Supportive Care
  • Cervical Cancer
  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Sarcoma
  • Vaginal Cancer
  • Vulvar Cancer
  • Dietary Supplement: therapeutic nutritional supplementation
    Patients receive systematic nutritional supplementation
  • Procedure: standard follow-up care
    Patients undergo standard monitoring
  • No Intervention: Arm I
    Patients are monitored via standard follow-up assessments every 3 weeks.
    Intervention: Procedure: standard follow-up care
  • Experimental: Arm II
    Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.
    Interventions:
    • Dietary Supplement: therapeutic nutritional supplementation
    • Procedure: standard follow-up care
  • 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.
    Interventions:
    • Dietary Supplement: therapeutic nutritional supplementation
    • Procedure: standard follow-up care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
Not Provided
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00905658
CDR0000633553
COL-NUTRYS
COL-2007-06
COL-IDRCB-2007-A00454-49
INCA-RECF0634
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Centre Oscar Lambret
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Principal Investigator: Isabelle Rodrigues-Lebrun Centre Oscar Lambret
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP