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Trial Title:
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
NCT ID:
NCT00905658
Condition:
Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer
Conditions: Official terms:
Sarcoma
Uterine Cervical Neoplasms
Endometrial Neoplasms
Fallopian Tube Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Primary purpose:
Supportive Care
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
therapeutic nutritional supplementation
Description:
Patients receive systematic nutritional supplementation
Arm group label:
Arm II
Arm group label:
Arm III
Intervention type:
Procedure
Intervention name:
standard follow-up care
Description:
Patients undergo standard monitoring
Arm group label:
Arm I
Arm group label:
Arm II
Arm group label:
Arm III
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Oscar Lambret
Address:
City:
Lille
Zip:
59020
Country:
France
Status:
Recruiting
Contact:
Last name:
Isabelle Rodrigues-Lebrun
Phone:
33-32-029-5959
Start date:
June 2008
Lead sponsor:
Agency:
Centre Oscar Lambret
Agency class:
Other
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00905658
