Selenium in the Prevention of Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022165
Recruitment Status : Completed
First Posted : March 19, 2004
Last Update Posted : August 11, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: selenium Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Prevention Of Cancer By Intervention With Selenium
Study Start Date : October 1999
Actual Primary Completion Date : January 2002
Actual Study Completion Date : January 2002

Arm Intervention/treatment
Placebo Comparator: Placebo
Selenium yeast
Dietary Supplement: selenium
Experimental: Selenium yeast 100 micrograms per day
100 micrograms per day
Dietary Supplement: selenium
Experimental: Selenium yeast 200 micrograms per day
200 micrograms per day
Dietary Supplement: selenium
Experimental: Selenium yeast 300 micrograms per day
300 micrograms per day
Dietary Supplement: selenium

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022165

United Kingdom
Hammersmith Hospital
London, England, United Kingdom, W12 ONN
United Kingdom Coordinating Committee on Cancer Research-ABC
Sutton, England, United Kingdom, SM2 5NG
University Of Surrey
Guildford, United Kingdom, GU2 5XH
Sponsors and Collaborators
University of Surrey
Study Chair: Margaret Rayman, DPhil University of Surrey

Responsible Party: University of Surrey Identifier: NCT00022165     History of Changes
Other Study ID Numbers: CDR0000068791
First Posted: March 19, 2004    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by University of Surrey:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances