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

study id #: NCT00927485

condition: Familial Adenomatous Polyposis

status: completed

intervention:
Drug: Calcumin (Curcumin)
Other: Risk Factor Questionnaire
Other: Blood samples
Other: Biopsies (Sigmoidoscopy)
Other: Biopsies (Upper endoscopy)

start date: November 2007

estimated completion: November 2016

last updated: October 17, 2018

phase of development: Not Available

size / enrollment: 44

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:

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

investigators:
Marcia R. Cruz-Correa, MD, PhD

trial center locations: Puerto Rico