Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer

Lymphoma Clinical Trial

Official title: A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement

Status Completed

Clinical Trial Summary

RATIONALE: Nutritional supplements may help prevent loss of appetite, weight loss, and fatigue in patients with advanced cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two nutritional supplements in preventing loss of appetite, weight loss, and fatigue in patients who have stage III or stage IV solid tumors.

Clinical Trial Description

OBJECTIVES:

• Compare the change in lean body mass of patients treated with Juven® vs a non-Juven® supplement.

• Compare the change in fatigue and quality of life of patients treated with these supplements.

• Compare the results of plethysmography, bioimpedance, and skinfold measurement in patients treated with these supplements.

• Compare the weight change in patients treated with these supplements.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to primary disease site (lung vs others), concurrent chemotherapy (yes vs no), evidence of metastases (yes vs no), and degree of weight loss (2-5% vs 6-10%). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral Juven® supplement twice daily for 8 weeks.

• Arm II: Patients receive oral non-Juven® supplement twice daily for 8 weeks. All patients undergo lean body mass measurement (to include multiple body composition and weight change) and fatigue and quality of life assessments at baseline and then at 4 and 8 weeks.

PROJECTED ACCRUAL: A total of 468 patients (234 per treatment arm) will be accrued for this study within 16 months. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cachexia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00053053
• Study type: Interventional
• Source: Radiation Therapy Oncology Group
• Status: Completed
• Phase: Phase 3
• Start date: December 2002
• Completion date: February 2009