The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon

Conditions
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Aberrant Crypt Foci

Intervention / Treatment
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* Drug: sulindac
* Drug: curcumin


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sulindac|Sulindac 150 mg po BID|
|Drug: curcumin|Curcumin 250 mg po BID|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aberrant Crypt Foci