NCT00641147

Curcumin in Treating Patients With Familial Adenomatous Polyposis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Familial Adenomatous Polyposis

Interventions

Type	Name	Description
DRUG	Curcumin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo	Given PO

Timeline

• Start date: 2010-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-30
• First posted: 2008-03-24
• Last updated: 2017-09-29
• Results posted: 2017-09-29

Locations

2 sites across 2 countries: United States, Puerto Rico