NCT00022165

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 1999

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

March 19, 2004

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

August 10, 2001

Last Update Submit

August 10, 2015

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Selenium yeast

Dietary Supplement: selenium

Selenium yeast 100 micrograms per day

EXPERIMENTAL

100 micrograms per day

Dietary Supplement: selenium

Selenium yeast 200 micrograms per day

EXPERIMENTAL

200 micrograms per day

Dietary Supplement: selenium

Selenium yeast 300 micrograms per day

EXPERIMENTAL

300 micrograms per day

Dietary Supplement: selenium

Interventions

seleniumDIETARY_SUPPLEMENT
PlaceboSelenium yeast 100 micrograms per daySelenium yeast 200 micrograms per daySelenium yeast 300 micrograms per day

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Hammersmith Hospital

London, England, W12 ONN, United Kingdom

Location

United Kingdom Coordinating Committee on Cancer Research-ABC

Sutton, England, SM2 5NG, United Kingdom

Location

University Of Surrey

Guildford, GU2 5XH, United Kingdom

Location

MeSH Terms

Interventions

Selenium

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Margaret Rayman, DPhil

    University of Surrey

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2001

First Posted

March 19, 2004

Study Start

October 1, 1999

Primary Completion

January 1, 2002

Study Completion

January 1, 2002

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

GB(3)