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Shiitake Mushrooms
In Prostate Cancer Trial at UC

Pilot study, first U.S. human trial of Japanese nutritional supplement

December 28, 1998. Investigators at UC Davis are studying a nutritional supplement derived from mushrooms to see if it can reduce tumor activity in men with prostate cancer.
     The six-month pilot study is the first human trial outside of Japan using the substance known as activated hexose-containing compound, an active fraction found in shiitake mushrooms. This substance has shown anti-cancer properties in some human, animal and lab studies in Japan.
     Activated hexose-containing compound is also known as 1,3-beta glucan. The compound is sold in Japan, Europe and the United States as a nutritional supplement. It has no known side effects. The urology department at the UC Davis Medical Center is looking for men in the Sacramento area who have been treated for prostate cancer yet show rising levels of prostate specific antigen (PSA), a protein secreted by the prostate gland.
     In men who have been treated for prostate cancer, an elevated PSA almost always signifies recurrence. Results of the study, UC Davis Cancer Center's first complementary medicine trial, will be used to help decide whether a double blind, placebo-controlled study is warranted. No control group is being used in this initial phase.
     "We decided to go ahead with the study because the company which manufactures the mushroom extract has intriguing data to back up its claims," says Ralph deVere White, director of the UC Davis Cancer Center and co-principal investigator of the study. "The manufacturers have defined the mechanism for why it works. At the same time, we are treating it with the proper scientific oversight."
     Prostate cancer patients were selected for the first study because of the ease of measuring the tumor marker — elevated PSA, which shows up in a simple blood test. The men who participate will have their PSA, weight, blood chemistry and other factors monitored monthly.
     The fungi extract is used in more than 400 hospitals in Japan and Asia as a complementary therapy for different cancers. Almost 10,000 cancer patients take the supplement every day, according to data compiled by the company which makes the supplement. "We don't see it as a replacement for medical care, but if it works, it could offer patients and their physicians more options," says Robert Hackman, executive director of the Center for Complementary and Alternative Medicine Research at UC Davis. Hackman is co-principal investigator of the study.
     Human studies of activated hexose-containing compound conducted on cancer patients in Japanese hospitals showed some positive results. In addition, a peer-reviewed article published in the April 1998 issue of the journal Anti Cancer Drugs outlined animal studies at Hokkaido University School of Medicine which indicated that the compound may reduce tumor activity and lessen the side-effects of cancer treatment. "The substance seems to act like a natural biological response modifier, because it may increase the activity of natural killer cells and cytokines, which boost the immune system," says deVere White, who is chair of the urology department at the C Davis School of Medicine.
     Men in the study will take six grams of the nutritional supplement per 50 kilograms of body weight. For the average man, this works out to be anywhere from 16 to 25 gel caps of activated hexose-containing compound daily with meals. But don't try this at home, these doctors say — activated hexose-containing compound doesn't come from the shiitake mushrooms that you can buy in the grocery store, according to Hackman.
     Spores of shiitake and other mushrooms are cultivated in a high-tech factory in Sapporo until they sprout. The partially mature mushroom spores are treated in liquid broth with an enzyme which breaks down the cell wall and releases activated hexose-containing compound. This substance is in turn dried and harvested. "It would be very difficult for the average person to eat enough shiitake mushrooms to get activated hexose-containing compound in their system," says Hackman.
     To be eligible for the study, men must have been diagnosed with adenocarcinoma of the prostate and have had either a radical prostatectomy or radiation therapy with rising PSA; metastatic prostate cancer with no hormone treatment therapy; or metastatic prostate cancer that has failed hormone therapy. It is also open to men with elevated PSAs who do not want to pursue conventional medical therapy. The study will begin in late January. Results should be known within the year



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December 28, 1998

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