Expired Study
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Baltimore, Maryland 21287


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy 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. status/post (s/p) ileostomy Exclusion Criteria: - Female patients of childbearing age not on effective birth control - Pregnant women - White blood cell count (WBC) < 3500/ml - Platelet count < 100,000/ml - Blood urea nitrogen (BUN) > 25mg% - Creatinine > 1.5mg% - Patients unable to stop non-steroidal anti-inflammatory drugs (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 gastroesophageal reflux disease (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/Sidney Kimmel Cancer Center


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21287
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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