Neoplasms, ColorectalNCT02321969
Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer
A study testing GTE (green tea extract) in people with Neoplasms, Colorectal, run by Seoul National University Hospital.
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… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Neoplasms, Colorectal
- What is being tested?
- GTE (green tea extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects who present one or more adenomatous polyps on colonoscopy.
Who cannot join
- 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
About this study
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).
Read the 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.
- Conditions
- Neoplasms, Colorectal
- Being tested
- GTE (green tea extract)
- Keywords
- Chemoprevention, Colorectal adenomatous polyp, Green tea extract
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTE (green tea extract)Dietary supplement
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]).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Without green tea extract (GTE) supplementation |
| GTE group | Experimental | GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps Receives: Dietary Supplement: GTE (green tea extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence/Number/Size of metachronous colorectal adenoma(s)
Measured: 1 year
Secondary outcomes (4)
Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s)
Measured: 1 year
Change of lipid profiles after green tea extract (GTE) supplementation
Measured: 1 year
Change of body weight, BMI and waist circumference
Measured: 1 year
Adverse effect(s) of GTE supplementation
Measured: every 1-3 months till the end of study protocol (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startAug 2010
- Primary completionMay 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, ColorectalStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Ho Lee, M.D., Ph.D., Principal investigator, Seoul National Universtiy Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321969
- Sponsor's protocol ID
- B-1006/103-002
- Status last verified
- Oct 2015
- First submitted
- 17 Dec 2014
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18990744Stingl 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.
PubMed 21851602Shin 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.
PubMed 28209333
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02321969
- Acronym / sponsor ID
- B-1006/103-002
- Conditions
- Neoplasms, Colorectal
- Keywords
- Chemoprevention, Colorectal adenomatous polyp, Green tea extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Without green tea extract (GTE) supplementation |
| GTE group | Experimental | Dietary Supplement: GTE (green tea extract)GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects who present one or more adenomatous polyps on colonoscopy.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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]). | Dietary supplement | GTE group |
Primary outcome
Recurrence/Number/Size of metachronous colorectal adenoma(s)
Time frame: 1 year
4 secondary outcomes
Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s)
Time frame: 1 year
Change of lipid profiles after green tea extract (GTE) supplementation
Time frame: 1 year
Change of body weight, BMI and waist circumference
Time frame: 1 year
Adverse effect(s) of GTE supplementation
Time frame: every 1-3 months till the end of study protocol (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Results publication: PubMed 18990744Shimizu 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 publication: PubMed 21851602Stingl 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.
- Derived from this study: PubMed 28209333Shin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Ho Lee, M.D., Ph.D. principal investigator
Seoul National Universtiy Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing GTE (green tea extract) in people with Neoplasms, Colorectal, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence/Number/Size of metachronous colorectal adenoma(s) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02321969, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.