NCT01360320

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,001 (actual)
• Sponsor: Martin-Luther-Universität Halle-Wittenberg · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Colorectal Serrated Adenomas
• Colorectal Tubular Adenomas
• Colorectal Villous Adenomas
• Colorectal Tubulovillous Adenomas

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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 * 150mg EGCG two times daily (p.o.) over the course of three years. * Colonoscopy after 3 years
DIETARY_SUPPLEMENT	Green tea extract of Camellia Sinensis followed by placebo	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

Timeline

• Start date: 2011-11-01
• Primary completion: 2019-05-01
• Completion: 2019-07-01
• First posted: 2011-05-25
• Last updated: 2019-09-20

Locations

21 sites across 1 country: Germany