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

Neoplasms, Colorectal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321969
• Other study ID #: B-1006/103-002
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: October 26, 2015
• Start date: August 2010
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasms, Colorectal

Intervention

Dietary Supplement:
• GTE (green tea extract)
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]).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

References & Publications (2)

Shimizu M, Fukutomi Y, Ninomiya M, Nagura K, Kato T, Araki H, Suganuma M, Fujiki H, Moriwaki H. Green tea extracts for the prevention of metachronous colorectal adenomas: a pilot study. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):3020-5. doi: 10.115 — View Citation

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 pla — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence/Number/Size of metachronous colorectal adenoma(s)		1 year	No
Secondary	Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s)		1 year	No
Secondary	Change of lipid profiles after green tea extract (GTE) supplementation		1 year	No
Secondary	Change of body weight, BMI and waist circumference		1 year	No
Secondary	Adverse effect(s) of GTE supplementation		every 1-3 months till the end of study protocol (12 months)	Yes