Spots Global Cancer Trial Database for Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
Official Title: Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
Study ID: NCT01360320
Study Description
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.
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ostalb-Klinikum Aalen, Medizinische Klinik 1, Sekretariat Prof. Kleber, Aalen, , Germany
Klinikum Altenburger Land, Gastroenterologie, Altenburg, , 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
Klinikum Esslingen, Klinik für Innere Medizin, Onkologie, Gastroenterologie, Esslingen, , Germany
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald, Klinik und Poliklinik für Innere Medizin A, Greifswald, , Germany
Dr. Zeisler, Praxis für Innere Medizin und Gastroenterologie, Halle, , Germany
Dres. Fechner/Behrens/Steudel - Gastroenterologisch-Onkologische Praxisklinik, Halle, , Germany
Dr. Frank-Gleich Praxis für Innere Medizin und Gastroenterologie, Halle, , Germany
Universitätsklinikum Halle, Klinik für Innere Medizin I, Halle, , Germany
Klinikum Ludwigsburg, Medizinische Klinik I, Ludwigsburg, , Germany
Diakoniekrankenhaus Mannheim, Medizinische Klinik II, Mannheim, , Germany
II. Medizinische Klinik und Poliklinik der TU München, Klinikum rechts der Isar, Munich, , Germany
Klinik Mühldorf Abt.Gastroenterologie, Mühldorf, , Germany
Klinikum Bogenhausen, Interdisziplinäre Onkologische Tagklinik, München, , Germany
Regio Kliniken Pinneberg, Pinneberg, , Germany
Klinikum St. Elisabeth, I. Medizinische Klinik, Straubing, , Germany
Universitätsklinikum Ulm, Klinik für Innere Medizin I, Ulm, , Germany
Evangelisches Krankenhaus Wesel, Abteilung Innere Medizin, Wesel, , Germany
Contact Details
Name: Julia Stingl, Prof.Dr.med
Affiliation: Federal Institute for Drugs and Medical Devices, Bonn, Germany
Role: STUDY_CHAIR
Name: Thomas Seufferlein, Prof.Dr.med.
Affiliation: University Hospital Ulm, Ulm, Germany
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
