Nutritional Supplements in Improving Quality of Life During First-Line Chemotherapy in Patients With Metastatic Gynecological Cancer

Centre Oscar Lambret

Status and phase: Unknown; Phase 2

Conditions: Endometrial Cancer; Sarcoma; Vulvar Cancer; Vaginal Cancer; Fallopian Tube Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Procedure: standard follow-up care; Dietary Supplement: therapeutic nutritional supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT00905658

COL-2007-06

CDR0000633553

COL-NUTRYS

INCA-RECF0634

COL-IDRCB-2007-A00454-49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

120 participants in 3 patient groups

Arm I

No Intervention group

Description:

Patients are monitored via standard follow-up assessments every 3 weeks.

Treatment:

Procedure: standard follow-up care

Arm II

Experimental group

Description:

Patients receive nutritional supplements and are monitored via standard follow-up assessments every 3 weeks.

Treatment:

Dietary Supplement: therapeutic nutritional supplementation

Procedure: standard follow-up care

Arm III

Experimental group

Description:

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.

Treatment:

Dietary Supplement: therapeutic nutritional supplementation

Procedure: standard follow-up care