Colon Cancer Prevention Using Selenium
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2010 |
| End Date: | December 2016 |
| Contact: | John A O'Toole, BA |
| Email: | jotool2@uic.edu |
| Phone: | 312-413-2446 |
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
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
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).
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