UK PREvention of Cancer by Intervention with SElenium

ISRCTN	ISRCTN25193534
DOI	https://doi.org/10.1186/ISRCTN25193534
ClinicalTrials.gov (NCT)	NCT00022165
Protocol serial number	N/A
Sponsor	Cancer Research UK (CRUK) (UK)
Funder	Cancer Research Campaign (UK) - funded a pilot trial for this study, completed in 2002

Submission date: 18/05/2001
Registration date: 18/05/2001
Last edited: 02/02/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Margaret Rayman
Scientific

Faculty of Health and Medical Sciences
University of Surrey
Guildford
GU2 5XH
United Kingdom

Phone	+44 (0)1483 686447
Email	M.Rayman@surrey.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	UK PREvention of Cancer by Intervention with SElenium: a pilot randomised controlled feasibility study
Study acronym	UK PRECISE Pilot Study
Study objectives	The PRECISE trial aims to show not only whether selenium has a protective effect against cancer, but also how much selenium is needed to have this effect and which people will benefit most. Added as of 27/03/2009: Please note that the main trial never started due to lack of funding. The pilot study was successfully completed, and the pilot trial information was added to this record on 12/07/2010. All changes can be found below in the relevant section with the above update date.
Ethics approval(s)	Added 13/07/2010: 1. South Tees Research Ethics Committee approved on the 1st February 2000 (ref: 99/69) 2. Worcestershire Health Authority Local Research Ethics Committee approved on the 17th March 2000 (ref: LREC 74/99) 3. Norwich District Research Ethics Committee approved on the 9th December 1999 (ref: LREC 99/141) 4. Great Yarmouth and Waveney LREC approved on the 22nd February 2000 (under reciprocal arrangements with Norwich District LREC)
Health condition(s) or problem(s) studied	Multiple cancer sites
Intervention	Current information as of 12/07/2010: Participants receive either a 100 µg, 200 µg, 300 µg selenium as selenium-enriched yeast supplement or a placebo yeast supplement every day for six months. Follow-up was for a minimum of six months (we had hoped this pilot would lead into the main trial phase). Previous information at time of registration: Participants receive either a 100 µg, 200 µg, 300 µg selenium supplement or a placebo every day.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Selenium
Primary outcome measure(s)	Added 12/07/2010: This was a feasibility study to show the ability to run the main trial.
Key secondary outcome measure(s)	Added 12/07/2010: 1. Mood (Profile of Mood States Bi-Polar Form [POMS-BI]), measured at baseline and 6 months 2. Quality of life (36-item Short Form Health Survey [SF-36]), measured at baseline and 6 months 3. Thyroid function (thyroid stimulating hormone [TSH], total and free T4 and T3), measured at baseline and six months
Completion date	31/12/2002

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	500
Key inclusion criteria	Volunteers aged 60 - 74 years old, either sex
Key exclusion criteria	Added 12/07/2010: 1. Southwest Oncology Group (SWOG) grading scale performance status score greater than 1 or equivalent 2. Active liver or kidney disease (known abnormal liver or kidney function) 3. Prior diagnosis of cancer (excluding non-melanoma skin cancer) 4. Diagnosed human immunodeficiency virus (HIV) infection 5. Diminished mental capacity (subjects must be able to give informed consent to participate as defined by ethics committees) 6. Taking 50 µg/day or more of selenium supplements
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Faculty of Health and Medical Sciences

Guildford
GU2 5XH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	selenium supplementation, mood and quality of life results	15/01/2006		Yes	No
Results article	selenium supplementation and thyroid function results	01/02/2008		Yes	No
Results article	high-selenium yeast on plasma lipids results	17/05/2011		Yes	No
Other publications	supplementation with selenium does not affect total homocysteine concentration in the UK elderly population:	01/11/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes