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

Aberrant Crypt Foci Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176618
• Other study ID #: 4611
• Secondary ID: CINJ#120305
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 10, 2009
• Start date: April 2004
• Est. completion date: June 2007

Study information

• Verified date: December 2009
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Aberrant Crypt Foci

Intervention

Drug:
• sulindac
Sulindac 150 mg po BID
• curcumin
Curcumin 250 mg po BID

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		48 months	No
Secondary	To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment		48 months	No