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| Name | Class |
|---|---|
| University of Ulm | OTHER |
| KKS Netzwerk | NETWORK |
| Deutsche Krebshilfe e.V., Bonn (Germany) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Green tea extract | Experimental | Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG, bid for 3 years |
|
| Placebo | Placebo Comparator | Placebo, packed in hard gelatine capsules, bid for 3 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Green tea extract of Camellia Sinensis | Dietary Supplement | Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrences of colorectal adenomas or mucosal lesions | 3 years | |
| Number of colorectal adenomas or mucosal lesions | 3 years | |
| Size of colorectal adenomas or mucosal lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Stingl, Prof.Dr.med | Federal Institute for Drugs and Medical Devices, Bonn, Germany | Study Chair |
| Thomas Seufferlein, Prof.Dr.med. | University Hospital Ulm, Ulm, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ostalb-Klinikum Aalen, Medizinische Klinik 1, Sekretariat Prof. Kleber | Aalen | 73430 | Germany | |||
| Klinikum Altenburger Land, Gastroenterologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21851602 | Background | Stingl JC, Ettrich T, Muche R, Wiedom M, Brockmoller J, Seeringer A, Seufferlein T. Protocol for minimizing the risk of metachronous adenomas of the colorectum with green tea extract (MIRACLE): a randomised controlled trial of green tea extract versus placebo for nutriprevention of metachronous colon adenomas in the elderly population. BMC Cancer. 2011 Aug 18;11:360. doi: 10.1186/1471-2407-11-360. | |
| 41039315 |
| Label | URL |
|---|---|
| Related Info | View source |
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| Green tea extract of Camellia Sinensis followed by placebo | Dietary Supplement | Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG
|
|
| 3 years |
| Localization of colorectal adenomas or mucosal lesions | 3 years |
| Histological subtypes of colorectal adenomas or mucosal lesions | 3 years |
| Invasive growth of colorectal adenomas or mucosal lesions | 3 years |
| Incidence of colorectal carcinoma | 3 years |
| Translational research | 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) | 3 years |
| Toxicity and feasibility | 3 years |
| Altenburg |
| 04600 |
| Germany |
| Klinikum Augsburg, III. Med. Klinik | Augsburg | 86156 | Germany |
| Krankenhaus Bietigheim-Bissingen, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie | Bietigheim-Bissingen | 74321 | Germany |
| Krankenhaus Buchholz, Abteilung Innere Medizin | Buchholz | 21244 | Germany |
| Kliniken der Stadt Köln gGmbH, Krankenhaus Holweide -Medizinische Klinik- | Cologne | Germany |
| Klinikum Esslingen, Klinik für Innere Medizin, Onkologie, Gastroenterologie | Esslingen am Neckar | 73730 | Germany |
| Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald, Klinik und Poliklinik für Innere Medizin A | Greifswald | 17475 | Germany |
| Dr. Zeisler, Praxis für Innere Medizin und Gastroenterologie | Halle | 06108 | Germany |
| Dres. Fechner/Behrens/Steudel - Gastroenterologisch-Onkologische Praxisklinik | Halle | 06108 | Germany |
| Dr. Frank-Gleich Praxis für Innere Medizin und Gastroenterologie | Halle | 06110 | Germany |
| Universitätsklinikum Halle, Klinik für Innere Medizin I | Halle | 06120 | Germany |
| Klinikum Ludwigsburg, Medizinische Klinik I | Ludwigsburg | 71640 | Germany |
| Diakoniekrankenhaus Mannheim, Medizinische Klinik II | Mannheim | 68163 | Germany |
| II. Medizinische Klinik und Poliklinik der TU München, Klinikum rechts der Isar | Munich | 81675 | Germany |
| Klinik Mühldorf Abt.Gastroenterologie | Mühldorf | 84453 | Germany |
| Klinikum Bogenhausen, Interdisziplinäre Onkologische Tagklinik | München | 81525 | Germany |
| Regio Kliniken Pinneberg | Pinneberg | 25421 | Germany |
| Klinikum St. Elisabeth, I. Medizinische Klinik | Straubing | 94315 | Germany |
| Universitätsklinikum Ulm, Klinik für Innere Medizin I | Ulm | 89081 | Germany |
| Evangelisches Krankenhaus Wesel, Abteilung Innere Medizin | Wesel | 46485 | Germany |
| Derived |
| Melzer A, Sturm N, Rohlmann F, Muche R, Stingl J, Ettrich TJ, Seufferlein T. Interest in complementary and alternative medicine among participants in a study on cancer prevention by green tea extract - results from an expert-based survey of MIRACLE trial participants. BMC Complement Med Ther. 2025 Oct 2;25(1):350. doi: 10.1186/s12906-025-05087-3. |
| 40433816 | Derived | Stingl J, Scholl C, Steffens M, Koczera P, Muche R, Rohlmann F, Ettrich T, Seufferlein T. Genomewide association analysis on green tea chemoprevention of colorectal adenoma: the importance of SLCO1A2 variants. Pharmacogenomics. 2025 Apr-Apr;26(5-6):157-164. doi: 10.1080/14622416.2025.2510186. Epub 2025 May 28. |
| 35213393 | Derived | Seufferlein T, Ettrich TJ, Menzler S, Messmann H, Kleber G, Zipprich A, Frank-Gleich S, Algul H, Metter K, Odemar F, Heuer T, Hugle U, Behrens R, Berger AW, Scholl C, Schneider KL, Perkhofer L, Rohlmann F, Muche R, Stingl JC. Green Tea Extract to Prevent Colorectal Adenomas, Results of a Randomized, Placebo-Controlled Clinical Trial. Am J Gastroenterol. 2022 Jun 1;117(6):884-894. doi: 10.14309/ajg.0000000000001706. Epub 2022 Feb 25. |
| 29466429 | Derived | Scholl C, Lepper A, Lehr T, Hanke N, Schneider KL, Brockmoller J, Seufferlein T, Stingl JC. Population nutrikinetics of green tea extract. PLoS One. 2018 Feb 21;13(2):e0193074. doi: 10.1371/journal.pone.0193074. eCollection 2018. |
| Related Info | View source |