Selenium in the Prevention of Cancer

NCT ID: NCT00022165

Last Updated: 2015-08-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2002-01-31

Brief Summary

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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

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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.

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Selenium yeast

Group Type PLACEBO_COMPARATOR

selenium

Intervention Type DIETARY_SUPPLEMENT

Selenium yeast 100 micrograms per day

100 micrograms per day

Group Type EXPERIMENTAL

selenium

Intervention Type DIETARY_SUPPLEMENT

Selenium yeast 200 micrograms per day

200 micrograms per day

Group Type EXPERIMENTAL

selenium

Intervention Type DIETARY_SUPPLEMENT

Selenium yeast 300 micrograms per day

300 micrograms per day

Group Type EXPERIMENTAL

selenium

Intervention Type DIETARY_SUPPLEMENT

Interventions

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selenium

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

60 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Surrey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

United Kingdom Coordinating Committee on Cancer Research-ABC

Sutton, England, United Kingdom

Site Status

University Of Surrey

Guildford, , United Kingdom

Site Status

Countries

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United Kingdom

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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