The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
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ClinicalTrials.gov Identifier: NCT00176618
Recruitment Status :
(principal Investigator left institution)
First Posted : September 15, 2005
Last Update Posted : December 11, 2009
University of Medicine and Dentistry of New Jersey
The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon.
Condition or disease
Aberrant Crypt Foci
Drug: sulindacDrug: curcumin
Laboratory studies have indicated that this agent, which is derived from plants and found in foods we eat, has anti-inflammatory properties and prevents colon cancer in animal studies. ACFs are small abnormalities in the lining of the colon that with time may grow into colorectal adenomas (also called polyps, growths or small masses of tissue on the lining of the colon or rectum which have the potential to become cancerous) which can then grow into adenocarcinomas (cancer) in the colon or rectum.
To evaluate the effects of curcumin or the NSAID sulindac on the number of ACF in the left colon and rectum of normal volunteers found to have them on an initial magnifying chromoendoscopic screening exam [ Time Frame: 48 months ]
Secondary Outcome Measures :
To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment [ Time Frame: 48 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects must be eligible for colorectal cancer (CRC) screening/surveillance by current criteria.
Subjects must have at least 5 ACF on eligibility chromosigmoidoscopy examination.
Subjects must not have:
Alcohol consumption of greater than 2 glasses of wine or beer per day or illicit recreational drug use
Platelet or coagulation abnormalities, or personal history of a bleeding disorder, including individuals taking warfarin.
High risk for developing endocarditis (history of endocarditis or rheumatic fever, cardiac valve prostheses, or mitral valve prolapse that requires antibiotic prophylaxis).
Uncontrolled hypertension, diabetes, or chronic congestive heart failure.
Renal insufficiency defined as a serum creatinine > 2.5 mg/dl
History of colorectal surgery with removal of the distal 60 cm of colon or rectum.
History of other gastrointestinal mucosal epithelial diseases (such as Barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue or other disorders of nutrient absorption).