Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
501 participants
INTERVENTIONAL
1999-10-31
2002-01-31
Brief Summary
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PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing cancer in healthy people.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
Selenium yeast
selenium
Selenium yeast 100 micrograms per day
100 micrograms per day
selenium
Selenium yeast 200 micrograms per day
200 micrograms per day
selenium
Selenium yeast 300 micrograms per day
300 micrograms per day
selenium
Interventions
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selenium
Eligibility Criteria
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Inclusion Criteria
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)
60 Years
74 Years
ALL
No
Sponsors
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University of Surrey
OTHER
Responsible Party
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Principal Investigators
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Margaret Rayman, DPhil
Role: STUDY_CHAIR
University of Surrey
Locations
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Hammersmith Hospital
London, England, United Kingdom
United Kingdom Coordinating Committee on Cancer Research-ABC
Sutton, England, United Kingdom
University Of Surrey
Guildford, , United Kingdom
Countries
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Other Identifiers
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SURREY-UK-PRECISE
Identifier Type: -
Identifier Source: secondary_id
EU-20113
Identifier Type: -
Identifier Source: secondary_id
CDR0000068791
Identifier Type: -
Identifier Source: org_study_id
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