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

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

Dr
Scientific

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

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not 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) studied	Multiple cancer sites
Intervention	Four treatment groups: 1. Placebo 2. 100 micrograms selenium/day 3. 200 micrograms selenium/day 4. 300 micrograms selenium/day
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	29/06/2001
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	52000
Key inclusion criteria	All those aged between 60 and 74 years are eligible.
Key exclusion criteria	1. 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 enrolment	01/01/1995
Date of final enrolment	29/06/2001

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan