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Metformin for the Prevention of CRA Recurrence

Primary Purpose

Colorectal Adenoma, Metformin, Chemoprevention

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low-dose metformin
high-dose metformin
Placebo
Sponsored by
Jing-yuan Fang, MD, Ph. D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Adenoma

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 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 HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

low-dose metformin group

high-dose metformin group

control group

Arm Description

low-dose metformin, 250mg/day

high-dose metformin, 500mg/day

placebo

Outcomes

Primary Outcome Measures

CRA recurrence rate
Percentage of patients who has recurrence of CRA(colorectal adenoma) during or after chemotherapy with metformin or placebo.

Secondary Outcome Measures

All polypoid lesions incidence rate
Percentage of patients who has incidence of all polypoid lesions during or after chemotherapy with metformin or placebo.
CRC incidence rate
Percentage of patients who has incidence of CRC (colorectal cancer) during or after chemotherapy with metformin or placebo.

Full Information

First Posted
November 29, 2020
Last Updated
May 12, 2021
Sponsor
Jing-yuan Fang, MD, Ph. D
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1. Study Identification

Unique Protocol Identification Number
NCT04885426
Brief Title
Metformin for the Prevention of CRA Recurrence
Official Title
The Role of Metformin in the Prevention for Colorectal Adenoma Recurrence in Post-polypectomy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing-yuan Fang, MD, Ph. D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma, Metformin, Chemoprevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low-dose metformin group
Arm Type
Experimental
Arm Description
low-dose metformin, 250mg/day
Arm Title
high-dose metformin group
Arm Type
Experimental
Arm Description
high-dose metformin, 500mg/day
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
low-dose metformin
Intervention Description
Metformin Pill 250mg/day
Intervention Type
Drug
Intervention Name(s)
high-dose metformin
Intervention Description
Metformin Pill 500mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
CRA recurrence rate
Description
Percentage of patients who has recurrence of CRA(colorectal adenoma) during or after chemotherapy with metformin or placebo.
Time Frame
one year, two years
Secondary Outcome Measure Information:
Title
All polypoid lesions incidence rate
Description
Percentage of patients who has incidence of all polypoid lesions during or after chemotherapy with metformin or placebo.
Time Frame
one year, two years
Title
CRC incidence rate
Description
Percentage of patients who has incidence of CRC (colorectal cancer) during or after chemotherapy with metformin or placebo.
Time Frame
one year, two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 40-80 years without diabetes; CRAs removed without recurrence before recruitment; Must sign the consent form after being fully informed and understanding the purpose and procedure of this study. Exclusion Criteria: Familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome); Regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D; Have a history of gastrointestinal surgery; Have severe heart, liver or kidney disease ; Have cancer history; Women with pregnant, during breast-feeding period, or with expect pregnancy; Diabetes（taking diabetes medicines or HbA1c>6.5%); Inflammatory bowel disease; Mental illness; Intolerant to metformin; Cannot tolerate colonoscopy; Staffs in this clinical trial; Poor bowel preparation for colonoscopy or the examination time is shorter than 6 minutes; Unsuitable for inclusion by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-Yuan Fang, Professor
Phone
+8613918386561
Email
jingyuanfang@sjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Yuan Fang, Professor
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
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
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Yuan Fang, MD. Ph D.
Phone
+863386235037
Email
wangjilin811123@163.com
First Name & Middle Initial & Last Name & Degree
Jing-Yuan Fang, MD. Ph D.

12. IPD Sharing Statement

Learn more about this trial

Metformin for the Prevention of CRA Recurrence

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