Status:
COMPLETED
Curcumin in Treating Patients With Familial Adenomatous Polyposis
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Familial Adenomatous Polyposis
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorect...
Detailed Description
Specific Aims: I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and colore...
Eligibility Criteria
Inclusion
- Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir
- Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy
Exclusion
- Female patients of childbearing age not on effective birth control
- Pregnant women
- White blood cell count (WBC) \< 3500/ml
- Platelet count \< 100,000/ml
- Blood urea nitrogen (BUN) \> 25mg%
- Creatinine \> 1.5mg%
- Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial
- Malignancy other than nonmelanoma skin cancer
- Active bacterial infection
- Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)
- Patients with a history of peptic ulcer disease
- Patients on warfarin or plavix
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00641147
Start Date
October 1 2010
End Date
November 30 2016
Last Update
September 29 2017
Active Locations (2)
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1
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
2
University of Puerto Rico
San Juan, Puerto Rico, 00936