Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
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.
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: Juven
Dietary Supplement: Non-Juven Supplement
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement|
- Lean body mass [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
- Fatigue [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
- Body weight [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
- Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2002|
|Study Completion Date:||February 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Juven supplement
Juven nutritional supplement given twice a day for 8 weeks
|Dietary Supplement: Juven|
Active Comparator: Non-Juven supplement
Non-Juven nutritional supplement given twice a day for 8 weeks
|Dietary Supplement: Non-Juven Supplement|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053053
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|Study Chair:||Lawrence B. Berk, MD, PhD||CCOP - Columbus|