The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon - Full Text View

Sponsored by:	University of Medicine and Dentistry New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00176618

Purpose

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

Condition	Intervention
Aberrant Crypt Foci	Drug: sulindac Drug: curcumin

Drug Information available for: Sulindac Curcumin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

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 [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2004
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Sulindac 150 mg po BID

Curcumin 250 mg po BID

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176618

Locations

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

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Investigators

Principal Investigator:

Yang CS, MD

University of Medicine and Dentistry New Jersey

More Information

Responsible Party:	The Cancer Institute of New Jersey ( C. S. Yang, PhD )
Study ID Numbers:	4611, CINJ#120305
Study First Received:	September 13, 2005
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00176618
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:

Aberrant Crypt Foci

Study placed in the following topic categories:

Curcumin
Sulindac

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009