Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy
3 years
No
Julia Stingl, Prof.Dr.med
Study Chair
Institute of Pharmacology of Natural Products and Clinical Pharmacology, University Ulm, Germany
Germany: Ethics Commission
MIRACLE
NCT01360320
November 2011
March 2018
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