RATIONALE: American ginseng may help relieve cancer-related fatigue. PURPOSE: This clinical trial is studying how well American ginseng works in treating patients with cancer-related fatigue.
OBJECTIVES: Primary * Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo in patients with cancer-related fatigue. Secondary * Determine the toxic effects and tolerability of American ginseng in these patients. * Determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (I or II vs III or IV vs unknown), gender (male vs female), baseline fatigue score (4-7 vs 8-10), concurrent chemotherapy (yes vs no), and concurrent radiotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
290
Fatigue by brief inventory at 4 and 8 weeks of treatment
Time frame: at 4 and 8 weeks
Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment
Time frame: at 4 and 8 weeks
Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment
Time frame: at 4 and 8 weeks
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