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

University of Medicine and Dentistry of New Jersey

Status

Terminated

Conditions

Aberrant Crypt Foci

Treatments

Drug: sulindac

Drug: curcumin

Study type

Interventional

Funder types

Other

Identifiers

NCT00176618

4611

CINJ#120305

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (ACF) in the colon.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).