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

Last updated: August 5, 2024
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

3

Condition

Colon Cancer

Colorectal Cancer

Colon Polyps

Treatment

celecoxib and metformin combination

celecoxib monotherapy

Clinical Study ID

NCT06545526
4-2024-0371
  • Ages 20-55
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Patients with familial adenomatous polyposis(FAP) who are 20 to 55 years ofage.

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

Exclusion

Exclusion Criteria:

  1. FAP patients who had a history of colectomy within the previous 12 months orneed to undergo colectomy within 8 months after randomization.

  2. FAP patients with malignant disease, including colorectal cancer. 3. FAPpatients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirinthree or more times a week within 3 months of randomization.

  3. Pregnant or breast-feeding patients. 5. Patients with cardiovascular diseases,peptic ulcer diseases and diabetes. 6. Patients with abnormal results of serumlaboratory tests (renal function and liver function test).

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: celecoxib and metformin combination
Phase: 3
Study Start date:
August 13, 2024
Estimated Completion Date:
June 30, 2026

Study Description

This clinical trial is 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. FAP patients, satisfied an enrollment criteria, will be randomly assigned in a 1:1 ratio to receive celecoxib monotherapy or combination of celecoxib and metformin orally for 6 months. The base-line and six-month endoscopic examination (colonoscopy/sigmoidoscopy and upper gastrointestinal endoscopy) will be recorded, and photographs will be taken at the tattoo-marked area. The number and size of polyps, and a qualitative assessment of the total extent of polyposis will be measured.

Connect with a study center

  • Department of Internal Medicine, Yonsei University College of Medicine

    Seoul, 120-752
    Korea, Republic of

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.