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Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis

NCT06545526 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-08-09

No results posted yet for this study

Summary

Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Metformin, an anti-diabetic drug, has recently been suggested to have a suppressive effect on tumorigenesis via inhibition of mTOR pathway, and have an inhibitory effect on polyp recurrence after removal of sporadic colorectal polyps. In addition, metformin has a number of potential mechnisms of carciovascular bebefit. We devised a randomized, open-label, comparative study to evaluate the effect of combination of celecoxib and metformin on polyps of colorectum and duodenum in FAP patients.

Conditions

Interventions

DRUG

celecoxib monotherapy

Patients will be randomly assigned in a 1:1 ratio to receive celecoxib monotherapy or combination of celecoxib and metformin orally for 6 months: celecoxib \[400mg, twice a day\] in arm 1, celecoxib \[400mg, twice a day\] and metformin \[1g, twice a day\] in arm 2.

DRUG

celecoxib and metformin combination

Patients will be randomly assigned in a 1:1 ratio to receive celecoxib monotherapy or combination of celecoxib and metformin orally for 6 months: celecoxib \[400mg, twice a day\] in arm 1, celecoxib \[400mg, twice a day\] and metformin \[1g, twice a day\] in arm 2.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2026-06-24
Completion
2026-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06545526 on ClinicalTrials.gov