Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00053053|
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : December 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cachexia Lymphoma Lymphoproliferative Disorder Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: Juven Dietary Supplement: Non-Juven Supplement||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||472 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||February 2009|
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
- Lean body mass [ Time Frame: Study entry to 8 weeks ]
- Fatigue [ Time Frame: Study entry to 8 weeks ]
- Quality of Life [ Time Frame: Study entry to 8 weeks ]
- Body weight [ Time Frame: Study entry to 8 weeks ]
- Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement [ Time Frame: Study entry to 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053053
|Study Chair:||Lawrence B. Berk, MD, PhD||CCOP - Columbus|