Colon Cancer Prevention Using Selenium
Status unconfirmed · Early Phase 1 · Has a placebo group
Conditions studied: Prevention of Colorectal Cancer
In brief
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
Key facts
- Study ID
- NCT01211561
- Run by
- University of Illinois at Chicago
- People needed
- 50
- Starts
- 2010-12-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2010-09-29
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- All non-pregnant patients >50 years of age
You may not qualify if…
- 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).
Where it is running
- University of Illinois at Chicago Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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