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

Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Aberrant Crypt Foci

Intervention: sulindac (Drug); curcumin (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Medicine and Dentistry of New Jersey

Official(s) and/or principal investigator(s):
Yang CS, MD, Principal Investigator, Affiliation: Rutgers, The State University of New Jersey

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: 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

Secondary outcome: To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, United States
Additional Information

Starting date: April 2004
Last updated: December 10, 2009

Page last updated: August 23, 2015

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