N/A
N=44
Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Familial Adenomatous Polyposis
Bottom Line
View on ClinicalTrials.gov: NCT00927485 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Polyps — 18.6; 22.6 Number of Polyps
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Calcumin (Curcumin) (Drug); Risk Factor Questionnaire (Other); Blood samples (Other); Biopsies (Sigmoidoscopy) (Other); Biopsies (Upper endoscopy) (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Puerto Rico
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Polyps |
18.6; 22.6 | — |
| PRIMARY Size of Polyps |
2.3; 2.1 | — |
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 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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00927485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.