Colorectal Serrated Adenomas Clinical Trial
— MIRACLEOfficial title:
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
| NCT number | NCT01360320 |
| Other study ID # | MIRACLE |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | November 2011 |
| Est. completion date | July 2019 |
| Verified date | September 2019 |
| Source | Martin-Luther-Universität Halle-Wittenberg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1001 |
| Est. completion date | July 2019 |
| Est. primary completion date | May 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | 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. Frank-Gleich Praxis für Innere Medizin und Gastroenterologie | Halle | |
| Germany | Dr. Zeisler, Praxis für Innere Medizin und Gastroenterologie | Halle | |
| Germany | Dres. Fechner/Behrens/Steudel - Gastroenterologisch-Onkologische Praxisklinik | 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 | Klinik Mühldorf Abt.Gastroenterologie | Mühldorf | |
| Germany | Klinikum Bogenhausen, Interdisziplinäre Onkologische Tagklinik | München | |
| Germany | II. Medizinische Klinik und Poliklinik der TU München, Klinikum rechts der Isar | Munich | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Martin-Luther-Universität Halle-Wittenberg | Deutsche Krebshilfe e.V., Bonn (Germany), KKS Netzwerk, University of Ulm |
Germany,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy | 3 years | ||
| Secondary | Occurrences of colorectal adenomas or mucosal lesions | 3 years | ||
| Secondary | Number of colorectal adenomas or mucosal lesions | 3 years | ||
| Secondary | Size of colorectal adenomas or mucosal lesions | 3 years | ||
| Secondary | Localization of colorectal adenomas or mucosal lesions | 3 years | ||
| Secondary | Histological subtypes of colorectal adenomas or mucosal lesions | 3 years | ||
| Secondary | Invasive growth of colorectal adenomas or mucosal lesions | 3 years | ||
| Secondary | Incidence of colorectal carcinoma | 3 years | ||
| Secondary | 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 | |
| Secondary | Toxicity and feasibility | 3 years |