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Lead
Centre Oscar Lambret
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.
Age
18–65
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer
