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

Phase 2
50 Years
80 Years
Open (Enrolling)
Colorectal Serrated Adenomas, Colorectal Tubular Adenomas, Colorectal Villous Adenomas, Colorectal Tubulovillous Adenomas

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Trial Information

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.

Inclusion Criteria:

- Between 50-80 years of age

- Histologically confirmed colorectal adenomas or serrated lesions removed during
colonoscopy within the last 6 months

- Good performance status (ECOG < 2) at study entrance

- Written informed consent.

Exclusion Criteria:

- History of hereditary nonpolyposis colorectal cancer (HNPCC) or familial adenomatous
polyposis (FAP)

- History of colon or rectal cancer, other concomitant cancers with the exemption of
basalioma or curative treated cancers without actual anticancer medication.

- Intestinal malabsorption, short bowel syndrome or surgical bowel interventions
leading to malabsorption

- Liver failure (hepatitis, cirrhosis, elevation of liver enzymes ALT, AST or bilirubin
to more than 2.5 fold of the reference levels)

- Inflammatory bowel disease

- Regular intake of NSAIDs (also Cox2 inhibitors) for more than 3 months per year
except of low-dose aspirin (100 mg per day)

- Immunosuppressive medication

- Impaired capacity to consent or who are impaired in swallowing a pill

- Regular consumption of green tea extract as nutritional supplement (with a content of
EGCG of more than 100mg per day) of longer than 6 months during the past two years

- Allergic reactions towards green tea

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Julia Stingl,

Investigator Role:

Study Chair

Investigator Affiliation:

Institute of Pharmacology of Natural Products and Clinical Pharmacology, University Ulm, Germany


Germany: Ethics Commission

Study ID:




Start Date:

November 2011

Completion Date:

March 2018

Related Keywords:

  • Colorectal Serrated Adenomas
  • Colorectal Tubular Adenomas
  • Colorectal Villous Adenomas
  • Colorectal Tubulovillous Adenomas
  • Green tea
  • polyphenol
  • catechin
  • EGCG
  • Epigallocatechin gallate
  • colorectal adenoma
  • adenoma prevention
  • colon cancer prevention
  • Adenoma
  • Adenoma, Villous