Minimizing the Risk of Metachronous Adenomas of the Colorectum With Green Tea Extract -MIRACLE-
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,001
- 试验地点
- 41
- 主要终点
- Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy
研究概览
简要总结
This is a randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.
详细描述
Prevention of colorectal cancer is a major health care issue because of the high incidence of this cancer. So far, pharmaceutical chemoprevention has not gained widespread acceptance due to side effects of the chemopreventive agents used. Nutraceuticals such as polyphenols from tea plants have demonstrated remarkable therapeutic and preventive effects in molecular, epidemiological and clinical trials. However, controlled trials demonstrating the efficacy of nutraceuticals fo the prevention of colorectal cancer are largely missing.
The investigators present this randomized, placebo controlled, multicentric trial to investigate the effect of diet supplementation with green tea extract containing 300mg epigallocatechin gallate (EGCG), the major polyphenol of green tea, on the recurrence of colon adenomas.
Patients who underwent polypectomy for colonic polyps will be randomized after a one month verum run-in period to receive either 150mg EGCG two times daily or placebo over the course of three years. The beneficial safety profile of decaffeinated green tea extract, the quantifiable and known active content EGCG, and the accumulating evidence on its cancer preventive potential require in our view a validation of this compound for the "nutriprevention" of colorectal adenoma. Good accessibility and low costs might render this nutraceutical a top candidate for a wider use as food supplement in colon cancer prevention.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 50-80 years of age
- •Histologically confirmed colorectal adenomas or serrated lesions removed during colonoscopy within the last 6 months
- •Good performance status (ECOG < 2) at study entrance
- •Written informed consent.
排除标准
- •History of hereditary nonpolyposis colorectal cancer (HNPCC) or familial adenomatous polyposis (FAP)
- •History of colon or rectal cancer, other concomitant cancers with the exemption of basalioma or curative treated cancers without actual anticancer medication.
- •Intestinal malabsorption, short bowel syndrome or surgical bowel interventions leading to malabsorption
- •Liver failure (hepatitis, cirrhosis, elevation of liver enzymes ALT, AST or bilirubin to more than 2.5 fold of the reference levels)
- •Inflammatory bowel disease
- •Regular intake of NSAIDs (also Cox2 inhibitors) for more than 3 months per year except of low-dose aspirin (100 mg per day)
- •Immunosuppressive medication
- •Impaired capacity to consent or who are impaired in swallowing a pill
- •Regular consumption of green tea extract as nutritional supplement (with a content of EGCG of more than 100mg per day) of longer than 6 months during the past two years
- •Allergic reactions towards green tea
研究组 & 干预措施
Green tea extract
Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG, bid for 3 years
干预措施: Green tea extract of Camellia Sinensis (Dietary Supplement)
Placebo
Placebo, packed in hard gelatine capsules, bid for 3 years
干预措施: Green tea extract of Camellia Sinensis followed by placebo (Dietary Supplement)
结局指标
主要结局
Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy
时间窗: 3 years
次要结局
- Number of colorectal adenomas or mucosal lesions(3 years)
- Size of colorectal adenomas or mucosal lesions(3 years)
- Localization of colorectal adenomas or mucosal lesions(3 years)
- Incidence of colorectal carcinoma(3 years)
- Occurrences of colorectal adenomas or mucosal lesions(3 years)
- Translational research(3 years)
- Toxicity and feasibility(3 years)
- Histological subtypes of colorectal adenomas or mucosal lesions(3 years)
- Invasive growth of colorectal adenomas or mucosal lesions(3 years)
研究者
Prof. Dr. med. Thomas Seufferlein
Prof. Dr. med.
Martin-Luther-Universität Halle-Wittenberg