Prevention Of Cancer By Intervention With Selenium
60 Years
74 Years
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Prevention Of Cancer By Intervention With Selenium
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.
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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Prevention
Principal Investigator
Margaret Rayman, DPhil
Investigator Role:
Study Chair
Investigator Affiliation:
University of Surrey
Authority:
United States: Federal Government
Study ID:
CDR0000068791
NCT ID:
NCT00022165
Start Date:
October 1999
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
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