Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer

Study Overview
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Brief Summary
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Experimental studies have shown the chemopreventive properties of green tea extract (GTE) on colorectal cancer. And colorectal adenomas are precursors to colorectal cancers. The aim of this study is to determine the preventive effect of GTE supplements on metachronous colorectal adenomas by giving GTE tablets of which are equivalent of 9 cup-of-green tea per day (0.9 g/day GTE, 0.6 g/day Epigallocatechin gallate (EGCG).

Detailed Description
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The subjects who had undergone complete removal of colorectal adenomas by endoscopic polypectomy have been enrolled since June 2010. They were then randomized into two groups as follows: supplementation group (0.9 g GTE per day for 12 months) or control group without GTE supplementation. Follow-up colonoscopy was conducted in 12 months. A structured 72-h recall at baseline and the 1-year follow-up was used to assess dietary factors, and to evaluate rectal mucosal proliferation index (RMPI) using known proliferation markers (Ki-67/PCNA), at least 2 random biopsies of rectal mucosa were taken. A sample size of 176 patients (88 per each group) was calculated to give the study 80% power to detect a difference, assuming a two-sided significance test at the 0.05 level.

Official Title
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Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer

Conditions
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Neoplasms, Colorectal

Intervention / Treatment
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* Dietary Supplement: GTE (green tea extract)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - subjects who present one or more adenomatous polyps on colonoscopy. Exclusion Criteria: subjects who denied to participate in this study subjects who present inflammatory bowel diseases such as ulcerative colitis or crohn's disease subjects who received partial or total colectomy due to colon cancer or other colonic diseases. subjects who are pregnant subjects who are on aspirin or NSAIDS for any reasons subjects who have received a transplant of any major organ or who are on immunosuppressants for any reason subjects who are unable to perform a bowel prep or who present poor bowel prep for colonoscopy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Without green tea extract (GTE) supplementation | |
| Experimental: GTE group<br>GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps | Dietary Supplement: GTE (green tea extract)<br>* 6 GTE tablets per day. Daily dose is equivalent of 9 cup-of-green tea per day (0.9 g/day GTE, 0.6 g/day epigallocatechin gallate [EGCG]).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence/Number/Size of metachronous colorectal adenoma(s) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s) |  | 1 year | 
| Change of lipid profiles after green tea extract (GTE) supplementation |  | 1 year | 
| Change of body weight, BMI and waist circumference |  | 1 year | 
| Adverse effect(s) of GTE supplementation |  | every 1-3 months till the end of study protocol (12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemoprevention, Colorectal adenomatous polyp, Green tea extract