Clinical trial NCT00927485: Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Official title: Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Familial Adenomatous Polyposis
Keywords: Familial Adenomatous Polyposis (FAP)
Curcumin
Colorectal polyps
Duodenal polyps
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-06-25
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 (upper endoscopy and sigmoidoscopy) will be obtained.

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 \< 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

Primary outcomes:
measure: Number of Polyps
timeFrame: 5 years
measure: Size of Polyps
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Comprehensive Cancer Center
Study officials:
affiliation: University of Puerto Rico Comprehensive Cancer Center
name: Marcia R. Cruz-Correa, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cruz-Correa M, Hylind LM, Marrero JH, Zahurak ML, Murray-Stewart T, Casero RA Jr, Montgomery EA, Iacobuzio-Donahue C, Brosens LA, Offerhaus GJ, Umar A, Rodriguez LM, Giardiello FM. Efficacy and Safety of Curcumin in Treatment of Intestinal Adenomas in Patients With Familial Adenomatous Polyposis. Gastroenterology. 2018 Sep;155(3):668-673. doi: 10.1053/j.gastro.2018.05.031. Epub 2018 May 23.