The Chemopreventive Effect of Celecoxib Monotherapy Versus Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis: a Pilot Randomized, Open-label, Comparative Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 55
Healthy Volunteers: f
View:

• \- 1. Patients with familial adenomatous polyposis(FAP) who are 20 to 55 years of age.

• 2\. FAP patients who have colonic or duodenal polyp. 3. FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination.

Locations
Other Locations
Republic of Korea
Department of Internal Medicine, Yonsei University College of Medicine
RECRUITING
Seoul
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 28
Treatments
Active_comparator: celecoxib monotherapy
celecoxib \[400mg, twice a day\] for 6 months
Experimental: celecoxib and metformin combination
celecoxib \[400mg, twice a day\] and metformin \[1g, twice a day\] for 6 months
Related Therapeutic Areas
Sponsors
Leads: Yonsei University

This content was sourced from clinicaltrials.gov