Actively Recruiting
Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis
Led by Yonsei University · Updated on 2024-08-09
28
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with familial adenomatous polyposis (FAP) aged 20 to 55 years
- FAP patients who have polyps in the colon or duodenum
- FAP patients with five or more polyps measuring 2mm or larger seen by endoscopy
You will not qualify if you...
- History of colectomy in the past 12 months or planned colectomy within 8 months after randomization
- Malignant disease including colorectal cancer
- Use of NSAIDs or aspirin three or more times a week within 3 months before randomization
- Pregnant or breastfeeding patients
- Patients with cardiovascular disease, peptic ulcer disease, or diabetes
- Abnormal kidney or liver function test results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea, 120-752
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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