Study Stopped
principal Investigator left institution
The Effects of Curcuminoids on Aberrant Crypt Foci in the Human Colon
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2004
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 11, 2009
December 1, 2009
3.2 years
September 13, 2005
December 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To determine the turnover (proliferation, apoptosis, and differentiation) of colorectal epithelial cells in the crypts in situ in response to each treatment
48 months
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must be eligible for colorectal cancer (CRC) screening/surveillance by current criteria.
- Subjects must have at least 5 ACF on eligibility chromosigmoidoscopy examination.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yang CS, MD
Rutgers, The State University of New Jersey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
April 1, 2004
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
December 11, 2009
Record last verified: 2009-12