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Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis
Sponsor: Yonsei University
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.
Official title: 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
Key Details
Gender
All
Age Range
20 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2024-08-13
Completion Date
2026-06-30
Last Updated
2024-08-09
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea