Metformin for the Prevention of CRA Recurrence

• Sponsor: Jing-yuan Fang, MD, Ph. D (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04885426
• Collaborator: (none)
• Enrollment: 414
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 27
• Patients Per Site Per Month: 15.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Adenoma; Metformin; Chemoprevention	Drug: low-dose metformin; Drug: high-dose metformin; Drug: Placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 414 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: The Role of Metformin in the Prevention for Colorectal Adenoma Recurrence in Post-polypectomy Patients
• Actual Study Start Date: Aug 1, 2020
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	200001

Sponsors and Collaborators

• Jing-yuan Fang, MD, Ph. D

Investigators

• Study Director: Jing-Yuan Fang, Professor, Shanghai Jiao Tong University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jing-yuan Fang, MD, Ph. D, Director of Department of Gastroenterology, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT04885426
• Other Study ID Numbers: KY2019-019
• First Posted: May 13, 2021
• Last Update Posted: May 13, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenoma; Recurrence; Metformin

Study Results

No Results Posted as of May 13, 2021