Colorectal Serrated Adenomas Clinical Trial
Official title:
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
This is a randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.
Prevention of colorectal cancer is a major health care issue because of the high incidence of
this cancer. So far, pharmaceutical chemoprevention has not gained widespread acceptance due
to side effects of the chemopreventive agents used. Nutraceuticals such as polyphenols from
tea plants have demonstrated remarkable therapeutic and preventive effects in molecular,
epidemiological and clinical trials. However, controlled trials demonstrating the efficacy of
nutraceuticals fo the prevention of colorectal cancer are largely missing.
The investigators present this randomized, placebo controlled, multicentric trial to
investigate the effect of diet supplementation with green tea extract containing 300mg
epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of
colon adenomas.
Patients who underwent polypectomy for colonic polyps will be randomized after a one month
verum run-in period to receive either 150mg EGCG two times daily or placebo over the course
of three years. The beneficial safety profile of decaffeinated green tea extract, the
quantifiable and known active content EGCG, and the accumulating evidence on its cancer
preventive potential require in our view a validation of this compound for the
"nutriprevention" of colorectal adenoma. Good accessibility and low costs might render this
nutraceutical a top candidate for a wider use as food supplement in colon cancer prevention.
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