Status:
UNKNOWN
Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Cervical Cancer
Endometrial Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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 pha...
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. Seco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00905658
Start Date
June 1 2008
Last Update
July 29 2009
Active Locations (1)
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1
Centre Oscar Lambret
Lille, France, 59020