Metformin for the Prevention of CRA Recurrence

Colorectal Adenoma Clinical Trial

Official title:

The Role of Metformin in the Prevention for Colorectal Adenoma Recurrence in Post-polypectomy Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885426
• Other study ID #: KY2019-019
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: November 2022

Study information

• Verified date: May 2021
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jing-Yuan Fang, Professor
• Phone: +8613918386561
• Email: jingyuanfang[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Chemoprevention
• Colorectal Adenoma
• Metformin
• Recurrence

Intervention

Drug:
• low-dose metformin
Metformin Pill 250mg/day
• high-dose metformin
Metformin Pill 500mg/day
• Placebo
Placebo

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Jing-yuan Fang, MD, Ph. D

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	CRC incidence rate	Percentage of patients who has incidence of CRC (colorectal cancer) during or after chemotherapy with metformin or placebo.	one year, two years