The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study
- Compare the efficacy of American ginseng, administered at 3 different doses, vs placebo
in patients with cancer-related fatigue.
- 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.
- Arm I: Patients receive oral American ginseng twice daily for 8 weeks in the absence of
- Arm II: Patients receive oral American ginseng as in arm I, but at a higher dose.
- Arm III: Patients receive oral American ginseng as in arm I, but at a higher dose than
- Arm IV: Patients receive oral placebo twice daily for 8 weeks in the absence of
After 8 weeks of treatment, patients in arms I-III may continue to receive American ginseng
on the optional continuation portion of the study for an additional 8 weeks. Patients in arm
IV may begin oral American ginseng twice daily for 8 weeks on the optional continuation
portion of the study.
Quality of life is assessed at baseline, every 2 weeks during treatment, and at the end of
PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this
study within 35 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Fatigue by brief inventory at 4 and 8 weeks of treatment
Brent A. Bauer, MD
United States: Federal Government