A Phase 3 interventional study of Juven and Non-Juven Supplement in Cachexia, Lymphoma and Lymphoproliferative Disorder, sponsored by Radiation Therapy Oncology Group. Completed at 250 sites in 2 countries. Open to participants aged 17 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Supportive care
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.
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 468 patients (234 per treatment arm) will be accrued for this study within 16 months.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 472 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor or lymphoma with no leukemic aspect
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
No concurrent intestinal obstruction
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Juven nutritional supplement given twice a day for 8 weeks
Dietary Supplement: Juven
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
Showing the first 100 of 250 sites across 2 countries.
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Radiation Therapy Oncology Group