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

May 23, 2011
April 5, 2012
November 2011
March 2018   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01360320 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Colorectal Serrated Adenomas
  • Colorectal Tubular Adenomas
  • Colorectal Villous Adenomas
  • Colorectal Tubulovillous Adenomas
  • 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
  • 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
  • Experimental: Green tea extract
    Intervention: Dietary Supplement: Green tea extract of Camellia Sinensis
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Green tea extract of Camellia Sinensis followed by placebo
Stingl JC, Ettrich T, Muche R, Wiedom M, Brockmöller 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2941
March 2018
March 2018   (final data collection date for primary outcome measure)

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
Both
50 Years to 80 Years
No
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
Germany
 
NCT01360320
MIRACLE
Yes
Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg
Martin-Luther-Universität Halle-Wittenberg
  • University of Ulm
  • Koordinierungszentrum für Klinische Studien Halle
  • Deutsche Krebshilfe e.V., Bonn (Germany)
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
Martin-Luther-Universität Halle-Wittenberg
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP