Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-03 @ 8:38 AM
Study NCT ID:
NCT02321969
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2014-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-26', 'studyFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence/Number/Size of metachronous colorectal adenoma(s)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Recurrence/Number/Size of metachronous colorectal polyp(s) including hyperplastic polyp(s)', 'timeFrame': '1 year'}, {'measure': 'Change of lipid profiles after green tea extract (GTE) supplementation', 'timeFrame': '1 year'}, {'measure': 'Change of body weight, BMI and waist circumference', 'timeFrame': '1 year'}, {'measure': 'Adverse effect(s) of GTE supplementation', 'timeFrame': 'every 1-3 months till the end of study protocol (12 months)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chemoprevention', 'Colorectal adenomatous polyp', 'Green tea extract'], 'conditions': ['Neoplasms, Colorectal']}, 'referencesModule': {'references': [{'pmid': '18990744', 'type': 'RESULT', '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.'}, {'pmid': '21851602', 'type': 'RESULT', '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.'}, {'pmid': '28209333', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- subjects who present one or more adenomatous polyps on colonoscopy.\n\nExclusion Criteria:\n\n* subjects who denied to participate in this study\n* subjects who present inflammatory bowel diseases such as ulcerative colitis or crohn's disease\n* subjects who received partial or total colectomy due to colon cancer or other colonic diseases.\n* subjects who are pregnant\n* subjects who are on aspirin or NSAIDS for any reasons\n* subjects who have received a transplant of any major organ or who are on immunosuppressants for any reason\n* subjects who are unable to perform a bowel prep or who present poor bowel prep for colonoscopy"}, 'identificationModule': {'nctId': 'NCT02321969', 'briefTitle': 'Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer', 'orgStudyIdInfo': {'id': 'B-1006/103-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Without green tea extract (GTE) supplementation'}, {'type': 'EXPERIMENTAL', 'label': 'GTE group', 'description': 'GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps', 'interventionNames': ['Dietary Supplement: GTE (green tea extract)']}], 'interventions': [{'name': 'GTE (green tea extract)', 'type': 'DIETARY_SUPPLEMENT', '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\\]).', 'armGroupLabels': ['GTE group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dong Ho Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National Universtiy Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}