Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

Familial Adenomatous Polyposis Clinical Trial

Official title: Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

Status Completed

Clinical Trial Summary

Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.

Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.

Clinical Trial Description

Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained. ;

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyposis Coli
• Colorectal Neoplasms
• Familial Adenomatous Polyposis
• Nasopharyngeal Neoplasms

• NCT number: NCT00927485
• Study type: Interventional
• Source: University of Puerto Rico
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Completion date: December 2016