The Role of Metformin in the Prevention for Colorectal Adenoma Recurrence in Post-polypectomy Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- CRA recurrence rate
研究概览
简要总结
Most of the sporadic colorectal cancer (CRC )develop from colorectal adenoma (CRA), patients with CRA have a high risk of recurrence and development of metachronous CRA or CRC after removal, therefore, the investigators conducted this clinical trial to explore the chemoprevetion effect of metformin for CRA recurrence after removal.
详细描述
Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated.
Metformin is a widely used diabetes medicine. In recent years, anticancer activity of metformin has been explored. The aim of this study is to investigate the effect of metformin on the recurrence of colorectal adenomas by conducting a randomized, placebo-controlled, prospective clinical.
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)
盲法说明
The participant, investigator, data analyst, endoscopist and pathologist involved in this study are all blinded of which treatment the participants are receiving. The pharmaceutical company provided blinded bottles of study pills with the label 'A' , 'B' or 'C'. Unblinding will be advanced only in case of emergency.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 40-80 years without diabetes;
- •CRAs removed without recurrence before recruitment;
- •Must sign the consent form after being fully informed and understanding the purpose and procedure of this study.
排除标准
- •Familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome);
- •Regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D;
- •Have a history of gastrointestinal surgery;
- •Have severe heart, liver or kidney disease ;
- •Have cancer history;
- •Women with pregnant, during breast-feeding period, or with expect pregnancy;
- •Diabetes（taking diabetes medicines or HbA1c>6.5%);
- •Inflammatory bowel disease;
- •Mental illness;
- •Intolerant to metformin;
- •Cannot tolerate colonoscopy;
- •Staffs in this clinical trial;
- •Poor bowel preparation for colonoscopy or the examination time is shorter than 6 minutes;
- •Unsuitable for inclusion by the investigator
研究组 & 干预措施
low-dose metformin group
low-dose metformin, 250mg/day
干预措施: low-dose metformin (Drug)
high-dose metformin group
high-dose metformin, 500mg/day
干预措施: high-dose metformin (Drug)
control group
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
CRA recurrence rate
时间窗: one year, two years
Percentage of patients who has recurrence of CRA(colorectal adenoma) during or after chemotherapy with metformin or placebo.
次要结局
- CRC incidence rate(one year, two years)
- All polypoid lesions incidence rate(one year, two years)
研究者
Jing-yuan Fang, MD, Ph. D
Director of Department of Gastroenterology
Shanghai Jiao Tong University School of Medicine