Colon Cancer Prevention Using Selenium
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Prevention of Colorectal Cancer |
Drug: Selenium, selenomethionine Drug: placebo |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
- Reduction in ACF biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Selenium, selenomethionine |
Drug: Selenium, selenomethionine
Patients will receive one 200 ug pill of Selenomethionine
|
| Active Comparator: placebo |
Drug: placebo
Patients will be given one 200 ug placebo pill each day for 6 months
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations| Contact: John A O'Toole, BA | 312-413-2446 | jotool2@uic.edu |
| United States, Illinois | |
| University of Illinois at Chicago Medical Center | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: John OToole, BA 312-413-2446 | |
| Principal Investigator: | Richard V Benya, MD | University of Illinois |
More Information
No publications provided
| Responsible Party: | Dr. Richard Benya, University of Illinois |
| ClinicalTrials.gov Identifier: | NCT01211561 History of Changes |
| Other Study ID Numbers: | 2008-1122 |
| Study First Received: | September 28, 2010 |
| Last Updated: | September 28, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Selenium Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013