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

Phase 3

Completed

• Conditions: Cachexia; Unspecified Adult Solid Tumor, Protocol Specific; Lymphoma; Lymphoproliferative Disorder

• Registration Number: NCT00053053
• Lead Sponsor: Radiation Therapy Oncology Group

Brief 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.

Detailed 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 Timeline

• Study Start: 2002-12
• Study First Submitted: 2003-01-27
• Study First Submitted QC: 2003-01-27
• Study First Posted: 2003-01-28
• Primary Completion: 2005-03
• Study Completion: 2009-02
• Status Verified: 2013-10
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lean body mass	Study entry to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Study entry to 8 weeks
Body weight	Study entry to 8 weeks
Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement	Study entry to 8 weeks
Fatigue	Study entry to 8 weeks

Trial Locations

Locations (250)

Comprehensive Cancer Center at University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Comprehensive Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

Montgomery Cancer Center; 🇺🇸 Montgomery, Alabama, United States

DCH Cancer Treatment Center; 🇺🇸 Tuscaloosa, Alabama, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Providence Saint Joseph Medical Center - Burbank; 🇺🇸 Burbank, California, United States

Mount Diablo Regional Cancer Center; 🇺🇸 Concord, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

California Cancer Center - Woodward Park Office; 🇺🇸 Fresno, California, United States

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