Condition category
Cancer
Date applied
18/05/2001
Date assigned
18/05/2001
Last edited
02/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Margaret Rayman

ORCID ID

Contact details

Faculty of Health and Medical Sciences
University of Surrey
Guildford
GU2 5XH
United Kingdom
+44 (0)1483 686447
M.Rayman@surrey.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00022165

Protocol/serial number

N/A

Study information

Scientific title

UK PREvention of Cancer by Intervention with SElenium: a pilot randomised controlled feasibility study

Acronym

UK PRECISE Pilot Study

Study hypothesis

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

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)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Selenium

Primary outcome measures

Added 12/07/2010:
This was a feasibility study to show the ability to run the main trial.

Secondary outcome measures

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

Overall trial start date

01/01/2000

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Volunteers aged 60 - 74 years old, either sex

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

14500 in total (500 for pilot arm - added 12/07/2010)

Participant 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

Recruitment start date

01/01/2000

Recruitment end date

31/12/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

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

Sponsor type

Charity

Website

http://www.cancerresearchuk.org/

Funders

Funder type

Charity

Funder name

Cancer Research Campaign (UK) - funded a pilot trial for this study, completed in 2002

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 selenium supplementation, mood and quality of life results in http://www.ncbi.nlm.nih.gov/pubmed/16181615
2. 2008 selenium supplementation and thyroid function results in http://www.ncbi.nlm.nih.gov/pubmed/18258627
3. 2008 supplementation with selenium does not affect total homocysteine concentration in the UK elderly population: http://www.ncbi.nlm.nih.gov/pubmed/18683819
4. 2011 high-selenium yeast on plasma lipids results in http://www.ncbi.nlm.nih.gov/pubmed/21576533

Publication citations

  1. Selenium supplementation and thyroid function results

    Rayman MP, Thompson AJ, Bekaert B, Catterick J, Galassini R, Hall E, Warren-Perry M, Beckett GJ, Randomized controlled trial of the effect of selenium supplementation on thyroid function in the elderly in the United Kingdom., Am. J. Clin. Nutr., 2008, 87, 2, 370-378.

  2. Supplementation with selenium does not affect total homocysteine concentration in the UK elderly population

    Bekaert B, Cooper ML, Green FR, McNulty H, Pentieva K, Scott JM, Molloy AM, Rayman MP, Effect of selenium status and supplementation with high-selenium yeast on plasma homocysteine and B vitamin concentrations in the UK elderly., Mol Nutr Food Res, 2008, 52, 11, 1324-1333, doi: 10.1002/mnfr.200700353.

  3. Rayman M, Thompson A, Warren-Perry M, Galassini R, Catterick J, Hall E, Lawrence D, Bliss J, Impact of selenium on mood and quality of life: a randomized, controlled trial., Biol. Psychiatry, 2006, 59, 2, 147-154, doi: 10.1016/j.biopsych.2005.06.019.

  4. Rayman MP, Stranges S, Griffin BA, Pastor-Barriuso R, Guallar E, Effect of supplementation with high-selenium yeast on plasma lipids: a randomized trial., Ann. Intern. Med., 2011, 154, 10, 656-665, doi: 10.7326/0003-4819-154-10-201105170-00005.

Additional files

Editorial Notes