A randomised double-blind placebo-controlled cancer prevention trial with an estimated duration of 5 years and with 52,000 subjects recruited from the general populations of the UK, Denmark, Sweden, Finland and the United States

ISRCTN ISRCTN64336220
DOI https://doi.org/10.1186/ISRCTN64336220
Secondary identifying numbers PRECISE
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
15/11/2013
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised double-blind placebo-controlled
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration

Added as of 27/03/2009: Please note that this trial never started due to lack of funding.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMultiple cancer sites
InterventionFour treatment groups:
1. Placebo
2. 100 micrograms selenium/day
3. 200 micrograms selenium/day
4. 300 micrograms selenium/day
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date29/06/2001
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants52,000
Key inclusion criteriaAll those aged between 60 and 74 years are eligible.
Key exclusion criteria1. Southwest Oncology Group (SWOG) performance status score of greater then 1 or equivalent
2. Active liver or kidney disease
3. Prior diagnosis of cancer
4. Diagnosed Human Immunodeficiency Virus (HIV) infection
5. Disminished mental capacity
6. Taking 50 micrograms/day or more of selenium supplements
Date of first enrolment01/01/1995
Date of final enrolment29/06/2001

Locations

Countries of recruitment

  • Denmark
  • England
  • Finland
  • Sweden
  • United Kingdom
  • United States of America

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan