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

Primary Purpose

Neoplasms, Colorectal

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

GTE (green tea extract)

About this trial

This is an interventional prevention trial for Neoplasms, Colorectal focused on measuring Chemoprevention, Colorectal adenomatous polyp, Green tea extract

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

GTE group

Arm Description

Without green tea extract (GTE) supplementation

GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps

Outcomes

Primary Outcome Measures

Recurrence/Number/Size of metachronous colorectal adenoma(s)

Secondary Outcome Measures

Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s)

Change of lipid profiles after green tea extract (GTE) supplementation

Change of body weight, BMI and waist circumference

Adverse effect(s) of GTE supplementation

Full Information

NCT ID

NCT02321969

First Posted

December 17, 2014

Last Updated

October 26, 2015

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02321969

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasms, Colorectal

Keywords

Chemoprevention, Colorectal adenomatous polyp, Green tea extract

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Without green tea extract (GTE) supplementation

Arm Title

GTE group

Arm Type

Experimental

Arm Description

GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps

Intervention Type

Dietary Supplement

Intervention Name(s)

GTE (green tea extract)

Intervention Description

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]).

Primary Outcome Measure Information:

Title

Recurrence/Number/Size of metachronous colorectal adenoma(s)

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s)

Time Frame

1 year

Title

Change of lipid profiles after green tea extract (GTE) supplementation

Time Frame

1 year

Title

Change of body weight, BMI and waist circumference

Time Frame

1 year

Title

Adverse effect(s) of GTE supplementation

Time Frame

every 1-3 months till the end of study protocol (12 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dong Ho Lee, M.D., Ph.D.

Organizational Affiliation

Seoul National Universtiy Bundang Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

18990744

Citation

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: 10.1158/1055-9965.EPI-08-0528.

Results Reference

result

PubMed Identifier

21851602

Citation

Stingl JC, Ettrich T, Muche R, Wiedom M, Brockmoller 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.

Results Reference

result

PubMed Identifier

28209333

Citation

Shin CM, Lee DH, Seo AY, Lee HJ, Kim SB, Son WC, Kim YK, Lee SJ, Park SH, Kim N, Park YS, Yoon H. Green tea extracts for the prevention of metachronous colorectal polyps among patients who underwent endoscopic removal of colorectal adenomas: A randomized clinical trial. Clin Nutr. 2018 Apr;37(2):452-458. doi: 10.1016/j.clnu.2017.01.014. Epub 2017 Jan 29.

Results Reference

derived

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

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