CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Calcumin (Curcumin) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00927485
NCT00927485N/ACompleted

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

University of Puerto Rico·interventional·Posted Jun 25, 2009·Updated Dec 16, 2020

In Brief

A clinical study evaluating Calcumin (Curcumin), Risk Factor Questionnaire, and 3 other interventions for Familial Adenomatous Polyposis. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2009
Enrollment StartNov 1, 2007
Primary CompletionNov 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 17.0 years ago

Interventions

Calcumin (Curcumin)drug

Patients will be randomized to curcumin (3 curcumin pills twice a day for 12 months).

Risk Factor Questionnaireother

Questions about current and past lifestyle, health background, and medications. This will take about 20 minutes.

Blood samplesother

Three tubes of blood at visits 0, 4 and 12 months.

Biopsies (Sigmoidoscopy)other

Flexible sigmoidoscopy at baseline and every 4 months for the length of the study (4 months, 8 months, 12 months and 16 months). We will take 2-4 tissue samples of the colon lining by a pinch biopsy.

Biopsies (Upper endoscopy)other

Other: Biopsies (Upper endoscopy) Upper endoscopy at baseline and at 12 months. We will take 2-4 tissue samples of the small intestine lining by a pinch biopsy.