Trials / Completed
CompletedNCT00053053
Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 472 (actual)
- Sponsor
- Radiation Therapy Oncology Group · Network
- Sex
- All
- Age
- 17 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Juven | |
| DIETARY_SUPPLEMENT | Non-Juven Supplement |
Timeline
- Start date
- 2002-12-01
- Primary completion
- 2005-03-01
- Completion
- 2009-02-01
- First posted
- 2003-01-28
- Last updated
- 2016-12-08
Locations
250 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00053053. Inclusion in this directory is not an endorsement.