American Ginseng in Treating Patients With Cancer-Related Fatigue
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.
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: American ginseng
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled Study|
- Fatigue by brief inventory at 4 and 8 weeks of treatment
- Sleep by Pittsburg Sleep Quality Inventory at 4 and 8 weeks of treatment
- Quality of life by North Central Cancer Treatment Group Uniscale at 4 and 8 weeks of treatment
|Study Start Date:||October 2005|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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 unacceptable toxicity.
- 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 II.
- Arm IV: Patients receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
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 treatment.
PROJECTED ACCRUAL: A total of 280 patients (70 per treatment arm) will be accrued for this study within 35 months.
|Study Chair:||Brent A. Bauer, MD||Mayo Clinic|
|Investigator:||Charles L. Loprinzi, MD||Mayo Clinic|
|Investigator:||Teresa A. Rummans, MD||Mayo Clinic|
|Investigator:||Tait D. Shanafelt, MD||Mayo Clinic|
|Investigator:||Patricia A. Johnson, MD, PhD||Carle Cancer Center at Carle Foundation Hospital|