Status:

TERMINATED

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

Lead Sponsor:

University of Medicine and Dentistry of New Jersey

Conditions:

Aberrant Crypt Foci

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

April 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2007

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00176618

Start Date

April 1 2004

End Date

June 1 2007

Last Update

December 11 2009

Active Locations (1)

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1

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08901