Colon Cancer Prevention Using Selenium
Primary Purpose
Prevention of Colorectal Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Selenium, selenomethionine
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- All non-pregnant patients >50 years of age
Exclusion Criteria:
The following will be specifically looked for, and result in patients not being eligible for study enrollment:
- Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.
- History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).
- Intake of any selenium supplements within 60 days of study entry, including vitamins.
- Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia).
Sites / Locations
- University of Illinois at Chicago Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Selenium, selenomethionine
placebo
Arm Description
Outcomes
Primary Outcome Measures
Reduction in ACF biomarkers
Secondary Outcome Measures
Full Information
NCT ID
NCT01211561
First Posted
September 28, 2010
Last Updated
September 28, 2010
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01211561
Brief Title
Colon Cancer Prevention Using Selenium
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
5. Study Description
Brief Summary
Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The investigators will directly assess selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an accepted surrogate marker for CRC.
ACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases.
The investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether selenized yeast supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Selenium, selenomethionine
Arm Type
Experimental
Arm Title
placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Selenium, selenomethionine
Intervention Description
Patients will receive one 200 ug pill of Selenomethionine
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Patients will be given one 200 ug placebo pill each day for 6 months
Primary Outcome Measure Information:
Title
Reduction in ACF biomarkers
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- All non-pregnant patients >50 years of age
Exclusion Criteria:
The following will be specifically looked for, and result in patients not being eligible for study enrollment:
Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.
History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).
Intake of any selenium supplements within 60 days of study entry, including vitamins.
Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John A O'Toole, BA
Phone
312-413-2446
Email
jotool2@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard V Benya, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John OToole, BA
Phone
312-413-2446
12. IPD Sharing Statement
Learn more about this trial
Colon Cancer Prevention Using Selenium
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