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

Launched by YONSEI UNIVERSITY · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the combined effects of two medications, celecoxib and metformin, on patients with a genetic condition called familial adenomatous polyposis (FAP). FAP can lead to the development of many polyps (growths) in the colon and duodenum, which can become cancerous over time. The goal of this trial is to see if this combination of drugs can help reduce the number of polyps and lower the risk of cancer in these patients. Celecoxib is known for its anti-inflammatory properties, while metformin is often used to treat diabetes and may have benefits for preventing tumors.

To participate in this study, patients need to be between 20 and 55 years old and have at least five polyps that are 2mm or larger in size. However, those who have had recent surgery on their colon, have cancer, or certain other health conditions won't be eligible. Participants in the trial can expect to receive the study medications and regular monitoring to check the effect on their polyps. This trial is currently recruiting participants, and it offers a potential new approach to managing FAP and preventing cancer.

Gender

ALL

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).