Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
Condition: Colorectal Serrated Adenomas; Colorectal Tubular Adenomas; Colorectal Villous Adenomas; Colorectal Tubulovillous Adenomas
MeSH terms: Adenoma; Adenoma, Villous
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Green tea extract of Camellia Sinensis; Green tea extract of Camellia Sinensis followed by placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Green tea; polyphenol; catechin; EGCG; Epigallocatechin gallate; colorectal adenoma; adenoma prevention; colon cancer prevention