The phase I study will determine whether Zyflamend, a herbal supplement commonly used as an anti-inflammatory, can prevent prostate cancer in patients with prostatic intraepithelial neoplasia (PIN).
PIN - meaning that the top layer of cells or epithelial cells of the prostate are dividing more rapidly than normal epithelial cells - is a clinical precursor for prostate cancer.Without intervention, men diagnosed with PIN have a 50 to 70 per cent likelihood of developing prostate cancer.
"Zyflamend has shown the ability, in vitro, to reduce prostate cancer cell proliferation by as much as 78 per cent and to induce cancer cell death or apoptosis," said Aaron Katz, principal investigator of the study. "These results are exceptionally promising and have led us to initiate this clinical trial."
The herbal, made by the nutritional supplements manufacturer New Chapter, is composed of 10 herbs - including rosemary, turmeric, ginger, holy basil, green tea, hu zhang, Chinese goldthread, barberry, oregano, and Baikal skullcap - that inhibit the cyclooxygenase-2 (COX-2) inflammation pathway. Long-term chronic inflammation contributes to carcinogenesis in many organ systems (the origin of certain cancers); inhibiting this pathway appears to be key to preventing cancers like prostate and colon cancer.
A herbal supplement may inhibit this pathway without causing the adverse gastrointestinal side effects associated with the long-term use of other COX-2 inhibitors. The preparation of this supplement differs from many herbal products in that it is not standardized to isolated chemicals. It delivers herbs in concentrated form, but the herbs retain their "food" status.
"We know more people are using herbal supplements as either their primary treatment or in tandem with their prescribed therapies, which is why it is important to study the safety and efficacy of herbal therapies," said Mark Blumenthal, founder and executive director of the American Botanical Council.
The Phase I study will evaluate the safety and tolerability of the herbal supplement in patients with PIN. Up to 48 men, between the ages of 40 and 75, will receive the herbal supplement three times a day for 18 months.
Prostate cancer is one of the biggest cancer killers in industrial countries and affects more than 500,000 men worldwide every year. This number is expected to increase with the ageing population.
In the US it is known that at least a quarter of all prostate cancer patients use alternative therapies, such as green tea.