Clinical Trial: Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Martin-Luther-Universität Halle-Wittenberg

Current Primary Outcome: Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occurrences of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ]
  • Number of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ]
  • Size of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ]
  • Localization of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ]
  • Histological subtypes of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ]
  • Invasive growth of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ]
  • Incidence of colorectal carcinoma [ Time Frame: 3 years ]
  • Translational research [ Time Frame: 3 years ]
    Genetic and biochemical biomarkers for recurrence of adenoma or development of dysplasia and carcinoma (blood samples and histological in tissue samples of the colorectal lesions)
  • Toxicity and feasibility [ Time Frame: 3 years ]


Original Secondary Outcome: Same as current

Information By: Martin-Luther-Universität Halle-Wittenberg

Dates:
Date Received: May 23, 2011
Date Started: November 2011
Date Completion: March 2018
Last Updated: April 5, 2012
Last Verified: April 2012