Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability
and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and
colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients
with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir)
II. To measure markers of cell proliferation including colorectal mucosal levels of
ornithine decarboxylase (ODC), polyamines, mucosal DNA methylation, proliferative index
(Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal
prostaglandin, leukotriene levels, and activation of the nuclear factor kappa B (NFKB), and
Akt survival pathways.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.
ARM II: Patients receive placebo PO BID for 12 months.
After completion of study treatment, patients are followed up at 4 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Total number of polyps
The average number of polyps in the treatment groups will be compared by the t-test (or a distribution free analog if distribution assumptions are not met). Multivariate regression models will be used to adjust for strongly predictive factors that are not balanced in the treatment groups.
Up to 16 months
Johns Hopkins University
United States: Food and Drug Administration
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