Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 主要终点
- Recurrence/Number/Size of metachronous colorectal adenoma(s)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who present one or more adenomatous polyps on colonoscopy.
排除标准
- •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
研究组 & 干预措施
Control
Without green tea extract (GTE) supplementation
GTE group
GTE supplementation for 12 months after polypectomy for colorectal adenomatous polyps
干预措施: GTE (green tea extract) (Dietary Supplement)
结局指标
主要结局
Recurrence/Number/Size of metachronous colorectal adenoma(s)
时间窗: 1 year
次要结局
- 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))
- 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)