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Epigallocatechin gallate

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Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG, bid for 3 years

Placebo, packed in hard gelatine capsules, bid for 3 years

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG

* Run-in period with 150mg EGCG two times daily (p.o) for 4 weeks
* 150mg EGCG two times daily (p.o.) over the course of three years.
* Colonoscopy after 3 years

Green tea extract of Camellia Sinensis

Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG

* Run-in period with 150mg EGCG two times daily (p.o.) for 4 weeks
* Placebo two times daily (p.o.) over the course of three years
* Colonoscopy after 3 years

Green tea extract of Camellia Sinensis followed by placebo

Julia Stingl, Prof.Dr.med

Thomas Seufferlein, Prof.Dr.med.

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.

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

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-	NCT01360320	Colorectal Serr... Colorectal Tubu... Colorectal Vill... Colorectal Tubu...	Green tea extra... Green tea extra...	50 Years - 80 Years	Martin-Luther-Universität Halle-Wittenberg
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-	NCT01360320	Colorectal Serr... Colorectal Tubu... Colorectal Vill... Colorectal Tubu...	Green tea extra... Green tea extra...	50 Years - 80 Years	Martin-Luther-Universität Halle-Wittenberg

Spots Global Cancer Trial Database for green tea extract of camellia sinensis