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

Ovarian Cancer Clinical Trial

Official title:

Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00905658
• Other study ID #: CDR0000633553
• Secondary ID: COL-NUTRYSCOL-20
• Status: Recruiting
• Phase: Phase 2
• First received: May 19, 2009
• Last updated: July 28, 2009
• Start date: June 2008

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Sarcoma
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Dietary Supplement:
• therapeutic nutritional supplementation
Patients receive systematic nutritional supplementation

Procedure:
• standard follow-up care
Patients undergo standard monitoring

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QLQ-C30)			No