Selenium in the Prevention of Cancer

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Dietary Supplement: selenium

• Registration Number: NCT00022165
• Lead Sponsor: University of Surrey

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 Timeline

• Study Start: 1999-10
• Study First Submitted: 2001-08-10
• Primary Completion: 2002-01
• Study Completion: 2002-01
• Study First Submitted QC: 2004-03-18
• Study First Posted: 2004-03-19
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selenium yeast 200 micrograms per day	selenium	200 micrograms per day
Selenium yeast 100 micrograms per day	selenium	100 micrograms per day
Placebo	selenium	Selenium yeast
Selenium yeast 300 micrograms per day	selenium	300 micrograms per day

Trial Locations

Locations (3)

Hammersmith Hospital; 🇬🇧 London, England, United Kingdom

United Kingdom Coordinating Committee on Cancer Research-ABC; 🇬🇧 Sutton, England, United Kingdom

University Of Surrey; 🇬🇧 Guildford, United Kingdom