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

NCT ID: NCT06545526

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2026-06-30

Brief 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.

Detailed 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.

Conditions

Familial Adenomatous Polyposis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

celecoxib monotherapy

celecoxib \[400mg, twice a day\] for 6 months

Group Type: ACTIVE_COMPARATOR

celecoxib monotherapy

Intervention Type: DRUG

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

celecoxib \[400mg, twice a day\] and metformin \[1g, twice a day\] for 6 months

Group Type: EXPERIMENTAL

celecoxib and metformin combination

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Internal Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

TAE IL KIM, MD

Role: primary

taeilkim@yuhs.ac

82-2-2228-1965

Other Identifiers

4-2024-0371

Identifier Type: -

Identifier Source: org_study_id