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

This study is currently recruiting participants.
Verified April 2012 by Martin-Luther-Universität Halle-Wittenberg
Sponsor:
Collaborators:
University of Ulm
Koordinierungszentrum für Klinische Studien Halle
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01360320
First received: May 23, 2011
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Serrated Adenomas
Colorectal Tubular Adenomas
Colorectal Villous Adenomas
Colorectal Tubulovillous Adenomas
 Dietary Supplement: Green tea extract of Camellia Sinensis
Dietary Supplement: Green tea extract of Camellia Sinensis followed by placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrences of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Number of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Size of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Localization of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Histological subtypes of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Invasive growth of colorectal adenomas or mucosal lesions [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Incidence of colorectal carcinoma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Translational research [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2941
Study Start Date: November 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Green tea extract Dietary Supplement: Green tea extract of Camellia Sinensis

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
Placebo Comparator: Placebo Dietary Supplement: Green tea extract of Camellia Sinensis followed by placebo

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

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360320

Contacts
Contact: Thomas Seufferlein, Prof.Dr.med. +49-345-557-0 ext 2661 thomas.seufferlein@medizin.uni-halle.de
Contact: Thomas J. Ettrich, Dr. med. +49-345-557-0 thomas.ettrich@medizin.uni-halle.de

Locations
Germany
Ostalb-Klinikum Aalen, Medizinische Klinik 1, Sekretariat Prof. Kleber Recruiting
Aalen, Germany, 73430
Contact: Caroline Walny         caroline.walny@ostalb-klinikum.de    
Principal Investigator: Gerhard Kleber, MD            
Klinikum Altenburger Land, Gastroenterologie Not yet recruiting
Altenburg, Germany, 04600
Contact: Michael Repp, MD         michael.repp@klinikum-altenburgerland.de    
Principal Investigator: Michael Repp, MD            
Klinikum Augsburg, III. Med. Klinik Recruiting
Augsburg, Germany, 86156
Contact: Tanja Hilmer         Tanja.Hilmer@klinikum-augsburg.de    
Krankenhaus Bietigheim-Bissingen, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie Recruiting
Bietigheim-Bissingen, Germany, 74321
Contact: Ulla Hegmann         hegmul01@kliniken-lb.de    
Principal Investigator: Siegfried Walker, MD            
Krankenhaus Buchholz, Abteilung Innere Medizin Recruiting
Buchholz, Germany, 21244
Contact: Dirk Fahrenholz, MD         Dirk.Fahrenholz@krankenhaus-buchholz.de    
Principal Investigator: Dirk Fahrenholz, MD            
Kliniken der Stadt Köln gGmbH, Krankenhaus Holweide -Medizinische Klinik- Recruiting
Cologne, Germany
Contact: Claudia Kaiser-Stolz         Kaiser-Stolz@kliniken-koeln.de    
Principal Investigator: Ulrich Huegle, MD            
Klinikum Esslingen, Klinik für Innere Medizin, Onkologie, Gastroenterologie Recruiting
Esslingen, Germany, 73730
Contact: Stephanie Klink         s.klink@kliniken-es.de    
Principal Investigator: Michael Geissler, MD            
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald, Klinik und Poliklinik für Innere Medizin A Recruiting
Greifswald, Germany, 17475
Contact: Eckhard Weber         eckhard.weber@uni-greifswald.de    
Principal Investigator: Julia Mayerle, MD            
Dr. Frank-Gleich Praxis für Innere Medizin und Gastroenterologie Recruiting
Halle, Germany, 06110
Contact: Ute Kabisch         u.kabisch@onkomedic.de    
Principal Investigator: Stefanie Frank-Gleich, MD            
Dres. Fechner/Behrens/Steudel - Gastroenterologisch-Onkologische Praxisklinik Recruiting
Halle, Germany, 06108
Contact: Anja Schlenk         bsf@gastro-halle.de    
Principal Investigator: Ruediger Behrens, MD            
Dr. Zeisler, Praxis für Innere Medizin und Gastroenterologie Recruiting
Halle, Germany, 06108
Contact: Brigitte Schneider         gastrozeisler@yahoo.de    
Principal Investigator: Thomas Zeisler, MD            
Universitätsklinikum Halle, Klinik für Innere Medizin I Recruiting
Halle, Germany, 06120
Contact: Teuber Evelin         evelin.teuber@medizin.uni-halle.de    
Principal Investigator: Thomas Seufferlein, MD            
Sub-Investigator: Thomas J. Ettrich, MD            
Klinikum Ludwigsburg, Medizinische Klinik I Recruiting
Ludwigsburg, Germany, 71640
Contact: Samuel Raad         samuel.raad@kliniken-lb.de    
Principal Investigator: Karel Caca, MD            
Diakoniekrankenhaus Mannheim, Medizinische Klinik II Recruiting
Mannheim, Germany, 68163
Contact: Ulrich Damian, MD         u.damian@diako-ma.de    
Principal Investigator: Ulrich Damian, MD            
II. Medizinische Klinik und Poliklinik der TU München, Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Jens Zimmermann         Studiensekretariat.med2@lrz.tum.de    
Principal Investigator: Jens T. Siveke, MD            
Klinik Mühldorf Abt.Gastroenterologie Recruiting
Mühldorf am Inn, Germany, 84453
Contact: Melanie Mühlberger         melanie.muehlberger@kliniken-muehldorf.de    
Principal Investigator: Gerhard Fuechsl, MD            
Klinikum Bogenhausen, Interdisziplinäre Onkologische Tagklinik Recruiting
München, Germany, 81525
Contact: Romy Petermann         romy.petermann@klinikum-muenchen.de    
Principal Investigator: Martin Fuchs, MD            
Regio Kliniken Pinneberg Not yet recruiting
Pinneberg, Germany, 25421
Contact: Stefan Tardos, MD         stefan.tardos@regiokliniken.de    
Principal Investigator: Stefan Tardos, MD            
Klinikum St. Elisabeth, I. Medizinische Klinik Recruiting
Straubing, Germany, 94315
Contact: Stefanie Wolf         stefanie.wolf@klinikum-straubing.de    
Principal Investigator: Weigert Norbert, MD            
Universitätsklinikum Ulm, Klinik für Innere Medizin I Recruiting
Ulm, Germany, 89081
Contact: Yvonne Kriebisch         yvonne.kriebisch@uniklinik-ulm.de    
Principal Investigator: Goetz von Wichert, MD            
Evangelisches Krankenhaus Wesel, Abteilung Innere Medizin Recruiting
Wesel, Germany, 46485
Contact: Adelheid Rosendahl         rosendahl@evkwesel.de    
Principal Investigator: Dirk Hartnack, MD            
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
University of Ulm
Koordinierungszentrum für Klinische Studien Halle
Deutsche Krebshilfe e.V., Bonn (Germany)
Investigators
Study Chair: Julia Stingl, Prof.Dr.med Institute of Pharmacology of Natural Products and Clinical Pharmacology, University Ulm, Germany
Principal Investigator: Thomas Seufferlein, Prof.Dr.med. University Hospital and Polyclinic for Internal Medicine I, Martin-Luther-University Halle, Germany
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Prof. Dr. med. Thomas Seufferlein, Prof. Dr. med., Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01360320     History of Changes
Other Study ID Numbers: MIRACLE
Study First Received: May 23, 2011
Last Updated: April 5, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
Green tea
polyphenol
catechin
EGCG
 Epigallocatechin gallate
colorectal adenoma
adenoma prevention
colon cancer prevention

Additional relevant MeSH terms:
Adenoma
Adenoma, Villous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013