Aberrant Crypt Foci
Conditions
Keywords
Aberrant Crypt Foci
Brief summary
The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon.
Detailed description
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.
Interventions
DRUGsulindac
Sulindac 150 mg po BID
DRUGcurcumin
Curcumin 250 mg po BID
Sponsors
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be eligible for colorectal cancer (CRC) screening/surveillance by current criteria. * Subjects must have at least 5 ACF on eligibility chromosigmoidoscopy examination.
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 48 months |
Secondary
| Measure | Time frame |
|---|---|
| To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment | 48 months |
Countries
United States
Outcome results
None listed