The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
18 Years
N/A
Both
Aberrant Crypt Foci
Trial Information
The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
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.
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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
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
Outcome Time Frame:
48 months
Safety Issue:
No
Principal Investigator
Yang CS, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Medicine and Dentistry New Jersey
Authority:
United States: Food and Drug Administration
Study ID:
4611
NCT ID:
NCT00176618
Start Date:
April 2004
Completion Date:
June 2007
Related Keywords:
- Aberrant Crypt Foci
- Aberrant Crypt Foci
- Aberrant Crypt Foci
Name | Location |
|---|---|
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
