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Mineral

Selenium, selenomethionine for Colorectal Cancer

Phase < 1
Waitlist Available
Led By Richard V Benya, MD
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- All non-pregnant patients >50 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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

Eligible Conditions
  • Colorectal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in ACF biomarkers

Side effects data

From 2012 Phase 3 trial • 35533 Patients • NCT00006392
13%
Nail changes
8%
Fatigue/malaise/lethargy
7%
Dermatitis
6%
Cardiac ischemia/infarction
6%
Halitosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Selenium Alone
Combination
Placebo
Vitamin E Alone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Selenium, selenomethionineExperimental Treatment1 Intervention
Group II: placeboActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
602 Previous Clinical Trials
1,558,461 Total Patients Enrolled
Richard V Benya, MDPrincipal InvestigatorUniversity of Illinois at Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025