ASCO 2012 Report – American Ginseng alleviates cancer related fatigue

by Marybeth Burke – Wisconsin grown ginseng significantly reduced cancer related fatigue in patients receiving cancer treatment after 8 weeks of ginseng treatment, researchers announced at the American Society of Clinical Oncology (ASCO) annual conference in Chicago in June.

The mean change from baseline in the general subscale of the Multidimensional Fatigue Symptom Inventory (MFSI) at 8 weeks was 20 for the ginseng arm vs 10 for the placebo arm, according to Debra L. Barton, RN, Ph.D., Mayo Clinic, Rochester, MN.

“This is only the second nutritional supplement to show effectiveness in reducing CFR,” said discussant, Karen Mustian, Ph.D., MPH, Assistant Professor of Radiation Oncology, University of Rochester Medical Center.  She referred to a 2010 study published in the Journal of Clinical Oncology (JCO) by M.P. Campos and others, that found guarana, a plant native to the Amazon basin, to be “an effective, cheap and nontoxic alternate for the treatment of fatigue in breast cancer patients receiving systemic chemotherapy,” according to JCO Vol. 28, May 20 Supplement.

Studies show that the prevalence of fatigue is 90-100% in patients receiving cancer treatment, Dr Barton said.  Fatigue can be present right after surgery, before chemotherapy or radiation even begins.  “It does increase during treatment and tends to get better within a month after treatment,” she said.

However, “We know that many patients don’t return to their baseline energy levels.  In some recent studies it’s been shown that survivors of breast cancer, about one quarter to one third, can have moderate to severe fatigue up to as much as ten years after diagnosis,” she said.

Ginseng Trial, Abstract #9001

Ginseng is a perennial plant popular in Chinese medicine and requires four years of growth to reach a potent effect.   It’s thought to possibly inhibit the (inflammatory) MAPkinase pathway, Dr Barton said.

In this Phase III double blind trial, patients with cancer undergoing or having completed curative intent treatment and experiencing fatigue, rated at least 4 on a numeric analogue fatigue scale (1-10) for ³ 1 month, were eligible.  Exclusion criteria included CNS lymphoma, brain malignancies, or prior use of ginseng or chronic systemic steroids, according to the abstract.

Patients were randomized to receive 2,000mg/d of American ginseng or placebo in BID dosing for 8 weeks.  Patients took capsules twice a day, both before noon.   Mean age was 55, and most were female and white and just over one half of the sample had breast cancer.  The primary endpoint was change from baseline in the general subscale in the MFSI at 4 weeks. Other MFSI subscales and the fatigue-inertia subscale of the Profile of Mood States were also analyzed.

From 10/2008 to 07/2011, 364 patients were enrolled.  “There were no statistically significant differences in any grade of toxicity or self reported side effects between ginseng and placebo,” according to the abstract.

“This trial provides data to support that American Ginseng reduces general and physical CRF over 8 weeks without side effects.  The treatment did not provide significant reductions in fatigue at 4 weeks and did not impact mental, emotional, and vigour dimensions of fatigue,”according to the study.

Dr Barton said that the effects of ginseng were demonstrated more consistently and earlier in the patients receiving treatment for cancer vs patients who had completed treatment.

“We want to more fully understand the post-treatment group and why they did not appear to get benefit,” she said and added that more work will be done to analyze and understand the mechanism at work.

Dr Mustian noted that current NCCN cancer related fatigue guidelines don’t currently specifically recommend nutritional supplements and asked, “Is it time to add recommendations about specific nutritional supplements?”