Metformin for the Prevention of CRA Recurrence

Jing-yuan Fang, MD, Ph. D

Status: Unknown

Conditions: Metformin; Colorectal Adenoma; Chemoprevention

Treatments: Drug: high-dose metformin; Drug: low-dose metformin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04885426

KY2019-019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 414 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 40-80 years without diabetes;
2. CRAs removed without recurrence before recruitment;
3. Must sign the consent form after being fully informed and understanding the purpose and procedure of this study.

Exclusion criteria

1. Familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome);
2. Regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D;
3. Have a history of gastrointestinal surgery;
4. Have severe heart, liver or kidney disease ;
5. Have cancer history;
6. Women with pregnant, during breast-feeding period, or with expect pregnancy;
7. Diabetes（taking diabetes medicines or HbA1c>6.5%);
8. Inflammatory bowel disease;
9. Mental illness;
10. Intolerant to metformin;
11. Cannot tolerate colonoscopy;
12. Staffs in this clinical trial;
13. Poor bowel preparation for colonoscopy or the examination time is shorter than 6 minutes;
14. Unsuitable for inclusion by the investigator

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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414 participants in 3 patient groups, including a placebo group

low-dose metformin group

Experimental group

Description:

low-dose metformin, 250mg/day

Treatment:

Drug: low-dose metformin

high-dose metformin group

Experimental group

Description:

high-dose metformin, 500mg/day

Treatment:

Drug: high-dose metformin

control group

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo