Actively Recruiting
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
Led by Yonsei University · Updated on 2024-08-09
28
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Familial adenomatous polyposis (FAP) is a condition that causes the development of many polyps in the colon and sometimes the duodenum, which can lead to cancer. Researchers are studying chemopreventive approaches to delay polyp and cancer growth in FAP patients. This study focuses on comparing the effects of celecoxib alone versus a combination of celecoxib and metformin on polyps in these patients, aiming to find safer prevention methods with fewer side effects than current treatments. Participants will be randomly assigned to one of two groups: one group will receive celecoxib alone at 400 mg twice daily, and the other group will receive celecoxib 400 mg twice daily combined with metformin 1 gram twice daily. Both treatments will be taken orally for six months. The study includes baseline and six-month endoscopic examinations of the colon, rectum, and upper gastrointestinal tract to assess the number, size, and overall extent of polyps, using photographs from marked areas. During the study, participants will undergo colonoscopy or sigmoidoscopy and upper gastrointestinal endoscopy at the start and end of treatment. Researchers will measure changes in polyp number and size as the primary outcome. They will also perform qualitative assessments of the overall polyposis extent. The study monitors participants for six months of treatment and includes careful evaluation of their response to the medications. The total duration of participation is about six months, with assessments focused on polyp changes and safety.
CONDITIONS
Brief 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 with colonic or duodenal polyps.
- FAP patients who have five or more polyps 2 mm or larger in diameter seen on endoscopy.
You will not qualify if you...
- FAP patients with a history of colectomy within the past 12 months or who need colectomy within 8 months after randomization.
- FAP patients with malignant disease, including colorectal cancer.
- FAP patients who used NSAIDs or aspirin three or more times a week within 3 months before randomization.
- Pregnant or breastfeeding patients.
- Patients with cardiovascular diseases, peptic ulcer disease, or diabetes.
- Patients with abnormal kidney or liver function test results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive oral celecoxib monotherapy or a combination of celecoxib and metformin for 6 months to assess their effect on colorectal and duodenal polyps.
Regular visits during treatment for medication administration and monitoring
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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