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.

Condition	Treatment or Intervention
general prevention of cancer	Drug: selenium

Further Study Details: 

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.

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (60-64 vs 65-69 vs 70-74). Patients are randomized to one of four treatment arms. Arm I: Patients receive oral placebo once daily. Arm II: Patients receive low-dose oral selenium once daily. Arm III: Patients receive moderate-dose oral selenium once daily. Arm IV: Patients 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.

Ages Eligible for Study:  60 Years   -   74 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Healthy men and women
• No prior diagnosis of cancer except non-melanoma skin cancer

--Prior/Concurrent Therapy--

• No other concurrent selenium supplements (50 ug/day or more)

--Patient Characteristics--

• Age: 60 to 74
• Performance status: SWOG 0
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: No active liver disease; No known abnormal liver function
• Renal: No active kidney disease; No known
• Other: HIV negative; No diminished mental capacity that would preclude study

United Kingdom
      University Of Surrey, Guildford,  GU2 5XH,  United Kingdom
United Kingdom, England
      Hammersmith Hospital, London,  England,  W12 ONN,  United Kingdom
      United Kingdom Coordinating Committee on Cancer Research-ABC, Sutton,  England,  SM2 5NG,  United Kingdom

Study chairs or principal investigators

Margaret Rayman,  Study Chair,  University of Surrey   

Study ID Numbers:  CDR0000068791; SURREY-UK-PRECISE; EU-20113
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022165
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08