Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
18 Years
65 Years
Female
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Vaginal Cancer, Vulvar Cancer
Trial Information
Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Quality of life (QLQ-C30)
Safety Issue:
No
Principal Investigator
Isabelle Rodrigues-Lebrun
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Oscar Lambret
Authority:
Unspecified
Study ID:
CDR0000633553
NCT ID:
NCT00905658
Start Date:
June 2008
Completion Date:
Related Keywords:
- Cervical Cancer
- Endometrial Cancer
- Fallopian Tube Cancer
- Ovarian Cancer
- Sarcoma
- Vaginal Cancer
- Vulvar Cancer
- 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
- Endometrial Neoplasms
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Vaginal Neoplasms
- Vulvar Neoplasms
- Fallopian Tube Neoplasms
- Adenoma
- Sarcoma
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