Status:
COMPLETED
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Lead Sponsor:
University of Puerto Rico
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Familial Adenomatous Polyposis
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
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 wi...
Detailed 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 (upp...
Eligibility Criteria
Inclusion
- 21-85 years with FAP (with an intact colon or who have had surgery)
Exclusion
- Mentally incompetent
- Female patients of childbearing age not on effective birth control
- Patients with WBC \< 3,500/ml, platelet count \< 100,000/ml, BUN \> 25mg%, creatinine \> 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00927485
Start Date
November 1 2007
End Date
December 1 2016
Last Update
December 16 2020
Active Locations (1)
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1
University of Puerto Rico Comprehensive Cancer Center
San Juan, Puerto Rico, 00936