NCT04885426

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
414

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

2.3 years

First QC Date

November 29, 2020

Last Update Submit

May 12, 2021

Conditions

Colorectal AdenomaMetforminChemoprevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • All polypoid lesions incidence rate

    one year, two years

  • CRC incidence rate

    one year, two years

Study Arms (3)

low-dose metformin group

EXPERIMENTAL

low-dose metformin, 250mg/day

Drug: low-dose metformin

high-dose metformin group

EXPERIMENTAL

high-dose metformin, 500mg/day

Drug: high-dose metformin

control group

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

low-dose metforminDRUG

Metformin Pill 250mg/day

low-dose metformin group
high-dose metforminDRUG

Metformin Pill 500mg/day

high-dose metformin group
PlaceboDRUG

Placebo

control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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 Municipality, 200001, China

RECRUITING

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jing-Yuan Fang, Professor

    Shanghai Jiao Tong University School of Medicine

    STUDY DIRECTOR

Central Study Contacts

Jing-Yuan Fang, Professor

CONTACT

+8613918386561jingyuanfang@sjtu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Department of Gastroenterology

Study Record Dates

First Submitted

November 29, 2020

First Posted

May 13, 2021

Study Start

August 1, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations

CN(1)