Metformin for the Prevention of CRA Recurrence

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Adenoma; Metformin; Chemoprevention
• Intervention / Treatment: Drug: Placebo; Drug: low-dose metformin; Drug: high-dose metformin

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 Type: Interventional
• Enrollment (Anticipated): 414
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing-Yuan Fang, Professor; Phone Number: +8613918386561; Email: jingyuanfang@sjtu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Recruiting
      • 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
      • Contact: Jing-Yuan Fang, MD. Ph D.; Phone Number: +863386235037; Email: wangjilin811123@163.com
      • Principal Investigator: Jing-Yuan Fang, MD. Ph D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low-dose metformin group; low-dose metformin, 250mg/day	Drug: low-dose metformin; Metformin Pill 250mg/day
Experimental: high-dose metformin group; high-dose metformin, 500mg/day	Drug: high-dose metformin; Metformin Pill 500mg/day
Placebo Comparator: control group; placebo	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Percentage of patients who has incidence of CRC (colorectal cancer) during or after chemotherapy with metformin or placebo.	one year, two years

Collaborators and Investigators

• Sponsor: Jing-yuan Fang, MD, Ph. D
• Investigators: Study Director: Jing-Yuan Fang, Professor, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Adenoma; Recurrence; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: KY2019-019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No