NCT01211561

Colon Cancer Prevention Using Selenium

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Prevention of Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Selenium, selenomethionine	Patients will receive one 200 ug pill of Selenomethionine
DRUG	placebo	Patients will be given one 200 ug placebo pill each day for 6 months

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-12-01
• Completion: 2016-12-01
• First posted: 2010-09-29
• Last updated: 2010-09-29

Locations

1 site across 1 country: United States