RecruitingPhase 3NCT06545526

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

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


Sponsor

Yonsei University

Enrollment

28 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two existing drugs — celecoxib (an anti-inflammatory) and metformin (a diabetes medication) — can help prevent the growth of polyps in people with familial adenomatous polyposis (FAP), a genetic condition that causes hundreds of polyps to grow in the colon and intestines, increasing cancer risk. **You may be eligible if...** - You are 20–55 years old with a diagnosis of FAP - You have polyps in the colon or small intestine (duodenum) - You have five or more polyps measuring 2mm or larger on endoscopy **You may NOT be eligible if...** - You had your colon removed within the past 12 months or need it removed within 8 months - You have colorectal cancer or other active cancer - You regularly use NSAIDs (like ibuprofen) or aspirin - You are pregnant or breastfeeding - You have cardiovascular disease, stomach ulcers, or diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcelecoxib 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.

DRUGcelecoxib 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

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NCT06545526


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