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A randomized, double-blind, placebo-controlled, multi-center clinical trial on the root of American ginseng (Panax ginseng L., Araliaceae) is being conducted to determine whether it can increase energy levels in patients with various types of cancer, according to a notice posted on the website of the National Cancer Institute (NCI). 1 Researchers are enrolling 280 patients aged 18 and over who have been diagnosed with cancer and who are experiencing cancer-related fatigue. The enrollment period will last for 35 months from September 2005 when the notice was initially posted. According to Debra Barton, PhD, a co-investigator of the study, the research team has already recruited 99 of the 280 patients needed for the study, and they are adding over 20 patients per month on study for the trial. [Personal communication (e-mail) to Courtney Cavalier, Feb. 27, 2006]
The primary objective for the trial is to compare the efficacy of American ginseng, root powder administered at 3 different doses [750 mg/day, 1,000 mg/day, and 2,000 mg/day], versus placebo in patients with cancer-related fatigue. The secondary objectives are (1) to determine the potential toxic effects and tolerability of American ginseng in these patients and (2) to determine the impact of American ginseng on quality of life-related variables (e.g., sleep, vitality, and quality of life domains) in these patients.
Patients will be administered American ginseng dried root powder in capsules, which are being supplied by the Ginseng Research Institute of Wausau, WI.
The patients will be 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 (placebo group) may begin oral American ginseng twice daily for 8 weeks on the optional continuation portion of the study. Quality of life will be assessed at baseline, every 2 weeks during treatment, and at the end of treatment.
A list of patient qualification / disqualification criteria is available on the NCI website. The principal investigators are Brent Bauer MD, Charles Loprinzi MD, Teresa Rummans MD, Tait Shanafelt MD, Debra Barton PhD, and Patricia A. Johnson MD, PhD at the North Central Cancer Treatment Group (NCCTG), a national research consortium sponsored by NCI. NCCTG is a network of cancer specialists and institutions from all over the US, Canada, and Mexico. Its research base is located at the Mayo Clinic in Rochester, Minn. The list of the numerous study sites, located in 19 states, and the eligibility criteria, is available at <http://cancer.gov/clinicaltrials/NCCTG-N03CA>.
Importance of This Trial
According to the NCI notice, “fatigue is a frequently debilitating symptom of cancer, as well as a common side effect of cancer treatment. Many cancer patients report experiencing extreme tiredness, exhaustion, and weakness, often severe enough to negatively affect their quality of life.”
Dr. Barton explained to HerbalEGram that the fatigue caused by cancer “is a fatigue that is not relieved by sleep. We do not have very effective, established treatments for cancer-related fatigue. We decided to pursue this study based on laboratory, animal, and pilot data for the use of ginseng for fatigue. Though much of the data are with Asian ginseng, there are data to suggest that both ginsenosides Rb1 and Rg1 [two of the primary active cmpounds in ginseng root] have ergogenic activity, and one difference between Asian and American ginseng is differential amounts of these two ginsenosides. Therefore, since both ginsenosides having the potential to be effective, we decided to study American ginseng as it is ‘locally’ grown and harvested.”
"Ginseng has a history of use in traditional medicine that suggests it may lessen the sense of fatigue that cancer patients experience, and some small studies have indicated that ginseng may have some efficacy as a remedy for fatigue," said Dr. Brent Bauer, principal investigator of this trial at the NCCTG, in the notice posted on the NCI website.1 "Consequently, many cancer patients are using ginseng on their own to combat fatigue. By studying ginseng in a controlled setting, we can better determine whether it has a beneficial effect for patients experiencing fatigue and, if there is a negative effect, we'll be able to better educate patients about the possible danger."
There have been only a few clinical trials conducted on American ginseng root preparations, most of them being in the past decade to test the herb’s ability to help normalize blood sugar level in type-2 diabetic and normal adults. Most serious clinical research on ginseng has been conducted on the more widely known and distributed Asian ginseng (Panax ginseng C.A. Meyer).
Contact Information
Anyone interested in more information on this trial can contact the NCI website for a list of study contacts (available at http://cancer.gov/clinicaltrials/NCCTG-N03CA) or by calling NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential
---Mark Blumenthal
Reference
1. NCI. Randomized study of American ginseng in patients with cancer-related fatigue. National Cancer Institute. Sep. 9, 2005, revised Feb. 17, 2006.
Available at <http://cancer.gov/clinicaltrials/NCCTG-N03CA>.
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