In a collaborative phase III trial of the North Central Cancer Treatment Group and Mayo Clinic reported in Journal of the National Cancer Institute by Debra L. Barton, RN, PhD, of the Mayo Clinic, and colleagues, patients with cancer-related fatigue were treated with Wisconsin ginseng (a common type of American ginseng) or placebo. Fatigue was significantly reduced in ginseng recipients at 8 weeks, and no discernible toxicities were associated with ginseng treatment.
Study Details
In this double-blind multi-institution study, 341 patients with cancer-related fatigue received 2,000 mg of Wisconsin ginseng in two daily doses (n = 171) or placebo (n = 170) for 8 weeks. Patients with all cancers, other than brain or central nervous system lymphoma, who were undergoing or had undergone curative treatment, and who had been diagnosed within the past 2 years were eligible for the study. The primary endpoint was change from baseline in the general subscale of the Multidimensional Fatigue Symptom Inventory–Short Form (MFSI-SF) at 4 weeks.
There were no significant differences between the ginseng and placebo groups at baseline for age (mean, 55 and 56 years), sex (81% and 75% female), race (91% and 92% white), menopausal status (22% and 18% premenopausal), type of cancer (breast in 64% and 57%, colon in 12% and 10%), or proportions currently receiving cancer treatment (49% in both groups).
Fatigue Significantly Reduced at 8 Weeks
At 4 weeks, mean (standard deviation) changes from baseline in the general subscale of the MFSI-SF were 14.4 points (27.1) in the ginseng group (n = 147 evaluable) and 8.2 points (24.8) in the placebo group (n = 153 evaluable) (P = .07). At 8 weeks, changes were 20 points (27) in the ginseng group (n = 138 evaluable) and 10.3 points (26.1) in the placebo group (n = 133 evaluable) (P = .003). Among patients currently undergoing cancer therapy, ginseng was associated with significant improvement in fatigue at both 4 weeks (P = .02) and 8 weeks (P = .01). More patients had a positive response to ginseng and more had a strong clinical benefit (≥ 30% improvement) compared with placebo.
No Appreciable Toxicity
Only five toxicities with a greater than 1% incidence were attributed to study treatments, consisting of nausea in 3% of ginseng patients and 2% of placebo patients, vomiting in 1% and 1%, insomnia on 6% and 7%, anxiety in 2% and 3%, and agitation in 1% and 2%. All of these adverse events were moderate except for severe insomnia in one patient in each group.
The investigators concluded: “Data support the benefit of American ginseng, 2,000 mg daily, on cancer-related fatigue over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve cancer-related fatigue are needed.”
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.