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Prevention Of Cancer By Intervention With Selenium

60 Years
74 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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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:


Study Design:

Primary Purpose: Prevention

Principal Investigator

Margaret Rayman, DPhil

Investigator Role:

Study Chair

Investigator Affiliation:

University of Surrey


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific