Metformin for the Prevention of CRA Recurrence

Not Applicable

• Conditions: Colorectal Adenoma; Metformin; Chemoprevention
• Interventions: Drug: high-dose metformin; Drug: Placebo; Drug: low-dose metformin

• Registration Number: NCT04885426
• Lead Sponsor: Jing-yuan Fang, MD, Ph. D

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-11-29
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Study First Posted: 2021-05-13
• Last Update Posted: 2021-05-13
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 414

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-dose metformin group	high-dose metformin	high-dose metformin, 500mg/day
control group	Placebo	placebo
low-dose metformin group	low-dose metformin	low-dose metformin, 250mg/day

Primary Outcome Measures

Name	Time	Method
CRA recurrence rate	one year, two years	Percentage of patients who has recurrence of CRA(colorectal adenoma) during or after chemotherapy with metformin or placebo.

Secondary Outcome Measures

Name	Time	Method
CRC incidence rate	one year, two years	Percentage of patients who has incidence of CRC (colorectal cancer) during or after chemotherapy with metformin or placebo.
All polypoid lesions incidence rate	one year, two years	Percentage of patients who has incidence of all polypoid lesions during or after chemotherapy with metformin or placebo.

Trial Locations

Locations (1)

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; 🇨🇳 Shanghai, Shanghai, China