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

Phase 2

Completed

• Conditions: Colorectal Serrated Adenomas; Colorectal Tubulovillous Adenomas; Colorectal Tubular Adenomas; Colorectal Villous Adenomas
• Interventions: Dietary Supplement: Green tea extract of Camellia Sinensis; Dietary Supplement: Green tea extract of Camellia Sinensis followed by placebo

• Registration Number: NCT01360320
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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 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.

Study Timeline

• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Study Start: 2011-11
• Primary Completion: 2019-05
• Study Completion: 2019-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1001

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Green tea extract	Green tea extract of Camellia Sinensis	Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG, bid for 3 years
Placebo	Green tea extract of Camellia Sinensis followed by placebo	Placebo, packed in hard gelatine capsules, bid for 3 years

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of colorectal adenomas or mucosal lesions	3 years
Size of colorectal adenomas or mucosal lesions	3 years
Localization of colorectal adenomas or mucosal lesions	3 years
Incidence of colorectal carcinoma	3 years
Occurrences of colorectal adenomas or mucosal lesions	3 years
Translational research	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	3 years
Histological subtypes of colorectal adenomas or mucosal lesions	3 years
Invasive growth of colorectal adenomas or mucosal lesions	3 years

Trial Locations

Locations (21)

Regio Kliniken Pinneberg; 🇩🇪 Pinneberg, Germany

Dr. Zeisler, Praxis für Innere Medizin und Gastroenterologie; 🇩🇪 Halle, Germany

Dr. Frank-Gleich Praxis für Innere Medizin und Gastroenterologie; 🇩🇪 Halle, Germany

Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald, Klinik und Poliklinik für Innere Medizin A; 🇩🇪 Greifswald, Germany

Dres. Fechner/Behrens/Steudel - Gastroenterologisch-Onkologische Praxisklinik; 🇩🇪 Halle, Germany

Klinikum St. Elisabeth, I. Medizinische Klinik; 🇩🇪 Straubing, Germany

Universitätsklinikum Halle, Klinik für Innere Medizin I; 🇩🇪 Halle, Germany

Klinikum Bogenhausen, Interdisziplinäre Onkologische Tagklinik; 🇩🇪 München, Germany

Klinikum Esslingen, Klinik für Innere Medizin, Onkologie, Gastroenterologie; 🇩🇪 Esslingen, Germany

II. Medizinische Klinik und Poliklinik der TU München, Klinikum rechts der Isar; 🇩🇪 Munich, Germany

Klinikum Ludwigsburg, Medizinische Klinik I; 🇩🇪 Ludwigsburg, Germany

Evangelisches Krankenhaus Wesel, Abteilung Innere Medizin; 🇩🇪 Wesel, Germany

Diakoniekrankenhaus Mannheim, Medizinische Klinik II; 🇩🇪 Mannheim, Germany

Klinik Mühldorf Abt.Gastroenterologie; 🇩🇪 Mühldorf, Germany

Universitätsklinikum Ulm, Klinik für Innere Medizin I; 🇩🇪 Ulm, Germany

Klinikum Augsburg, III. Med. Klinik; 🇩🇪 Augsburg, Germany

Krankenhaus Bietigheim-Bissingen, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie; 🇩🇪 Bietigheim-Bissingen, Germany

Krankenhaus Buchholz, Abteilung Innere Medizin; 🇩🇪 Buchholz, Germany

Kliniken der Stadt Köln gGmbH, Krankenhaus Holweide -Medizinische Klinik-; 🇩🇪 Cologne, Germany

Ostalb-Klinikum Aalen, Medizinische Klinik 1, Sekretariat Prof. Kleber; 🇩🇪 Aalen, Germany

Klinikum Altenburger Land, Gastroenterologie; 🇩🇪 Altenburg, Germany