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Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
study id #: NCT00927485
condition: Familial Adenomatous Polyposis
status: Active, not recruiting
purpose:Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.
Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.
intervention:
Drug: Calcumin (Curcumin)
Other: Risk Factor Questionnaire
Other: Blood samples
Other: Biopsies (Sigmoidoscopy)
Other: Biopsies (Upper endoscopy)
start date: November 2007
estimated completion: June 2017
last updated: December 12, 2016
phase of development: Not Available
size / enrollment: 50
study design:
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
study description:
Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.
primary outcomes:
- To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
inclusion criteria:
- 21-85 years with FAP (with an intact colon or who have had surgery)
exclusion criteria:
- Mentally incompetent
- Female patients of childbearing age not on effective birth control
- Patients with WBC 1.5mg%
- Patients unable to stop NSAIDS or aspirin use for the duration of the study
- Malignancy other than nonmelanoma skin cancer
- Active bacterial infection
- Patients with GERD (Gastro esophageal reflux disease) - Patients with a history of peptic (stomach or duodenal) ulcer disease
- Patients on Warfarin or anti-platelet drugs
sponsor: University of Puerto Rico
contacts:
Marcia R. Cruz-Correa, MD, PhD; 787-772-8300 ext 1214; marcia.cruz1@upr.edu
Jessica Hernandez, MS; 787-360-8917; jessica.hernandez8@upr.edu
investigators:
Marcia R. Cruz-Correa, MD, PhD
locations: Puerto Rico