Prevention Of Cancer By Intervention With Selenium
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Surrey
- Enrollment
- 501
- Locations
- 3
Study Overview
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Selenium may be effective in preventing cancer. It is not yet known which dose of selenium may be most effective in preventing cancer.
PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing cancer in healthy people.
Detailed Description
OBJECTIVES: I. Determine whether daily supplementation with selenium significantly reduces total cancer incidence and site-specific cancer incidence in the general population. II. Determine whether this regimen has a beneficial effect on mood.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to age (60-64 vs 65-69 vs 70-74). Participants are randomized to one of four arms. Arm I: Participants receive oral placebo once daily. Arm II: Participants receive low-dose oral selenium once daily. Arm III: Participants receive moderate-dose oral selenium once daily. Arm IV: Participants receive high-dose oral selenium once daily. Treatment in all arms continues for up to 2 years in the absence of unacceptable side effects or diagnosis of cancer.
PROJECTED ACCRUAL: A total of 510 patients (170 per stratum) will be accrued for this study within 9-12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 60 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS: Healthy men and women No prior diagnosis of cancer except non-melanoma skin cancer
- •PATIENT CHARACTERISTICS: Age: 60 to 74 Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No active liver disease No known abnormal liver function Renal: No active kidney disease No known abnormal kidney function Other: HIV negative No diminished mental capacity that would preclude study
- •PRIOR CONCURRENT THERAPY: No other concurrent selenium supplements (50 ug/day or more)
Exclusion Criteria
- Not provided
Arms & Interventions
Selenium yeast 300 micrograms per day
300 micrograms per day
Intervention: selenium (Dietary Supplement)
Selenium yeast 200 micrograms per day
200 micrograms per day
Intervention: selenium (Dietary Supplement)
Selenium yeast 100 micrograms per day
100 micrograms per day
Intervention: selenium (Dietary Supplement)
Placebo
Selenium yeast
Intervention: selenium (Dietary Supplement)