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

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City:		Baltimore
State:		Maryland
Zip Code:		21287

Conditions:		Familial Adenomatous Polyposis
Purpose:		This clinical 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
Study Summary:		PRIMARY OBJECTIVES: 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 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.
Criteria:		Inclusion Criteria: - Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total coloctomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir - Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. s/p ileostomy Exclusion Criteria: - Female patients of childbearing age not on effective birth control - Pregnant women - WBC < 3500/ml - Platelet count < 100,000/ml - BUN > 25mg% - Creatinine > 1.5mg% - Patients unable to stop NSAIDS, aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial - Malignancy other than nonmelanoma skin cancer - Active bacterial infection - Patients with symptoms of active GERD (symptomatic despite medication or current erosive esophagitis on endoscopy) - Patients with a history of peptic ulcer disease - Patients on Warfarin or Plavix
NCT ID:		NCT00641147
Primary Contact:		Principal Investigator Francis Giardiello Johns Hopkins University
Backup Contact:		N/A
Location Contact:		Baltimore, Maryland 21287 United States Francis M. Giardiello Phone: 410-955-2635 Email: fgiardi@jhmi.edu Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		May 20, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
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