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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose metformin group | Experimental | low-dose metformin, 250mg/day |
|
| high-dose metformin group | Experimental | high-dose metformin, 500mg/day |
|
| control group | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose metformin | Drug | Metformin Pill 250mg/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CRA recurrence rate | Percentage of patients who has recurrence of CRA(colorectal adenoma) during or after chemotherapy with metformin or placebo. | one year, two years |
| Measure | Description | Time Frame |
|---|---|---|
| All polypoid lesions incidence rate | Percentage of patients who has incidence of all polypoid lesions during or after chemotherapy with metformin or placebo. | one year, two years |
| CRC incidence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing-Yuan Fang, Professor | Contact | +8613918386561 | jingyuanfang@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jing-Yuan Fang, Professor | Shanghai Jiao Tong University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology & Hepatology, Ministry of Health | Recruiting | Shanghai | Shanghai Municipality | 200001 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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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.
| high-dose metformin |
| Drug |
Metformin Pill 500mg/day |
|
| Placebo | Drug | Placebo |
|
Percentage of patients who has incidence of CRC (colorectal cancer) during or after chemotherapy with metformin or placebo.
| one year, two years |
| China |
|