Familial Adenomatous Polyposis Clinical Trial
Official title:
Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.
Specific Aims:
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) surgery.
II. To measure markers of cell proliferation including colorectal mucosal levels of ornithine
decarboxylase (ODC), polyamines, mucosal deoxyribonucleic acid (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 v-akt murine thymoma viral oncogene homolog 1 (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.
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