Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE- (NCT01360320) | Clinical Trial Compass
CompletedPhase 2
Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
Germany1,001 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range50 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy