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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-06-30

Brief Summary

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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

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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.

Conditions

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Aberrant Crypt Foci

Keywords

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Aberrant Crypt Foci

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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sulindac

Sulindac 150 mg po BID

Intervention Type DRUG

curcumin

Curcumin 250 mg po BID

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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The Cancer Institute of New Jersey

Principal Investigators

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Yang CS, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CINJ#120305

Identifier Type: -

Identifier Source: secondary_id

4611