UK PREvention of Cancer by Intervention with SElenium
| ISRCTN | ISRCTN25193534 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25193534 |
| ClinicalTrials.gov number | NCT00022165 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Faculty of Health and Medical Sciences
University of Surrey
Guildford
GU2 5XH
United Kingdom
| Phone | +44 (0)1483 686447 |
|---|---|
| M.Rayman@surrey.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Selenium |
| Primary outcome measure | 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 study start date | 01/01/2000 |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 14500 in total (500 for pilot arm - added 12/07/2010) |
| 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
- England
- United Kingdom
Study participating centre
Faculty of Health and Medical Sciences
Guildford
GU2 5XH
United Kingdom
GU2 5XH
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
61 Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Website | http://www.cancerresearchuk.org/ |
|---|---|
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research Campaign (UK) - funded a pilot trial for this study, completed in 2002
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | |
| Other publications | supplementation with selenium does not affect total homocysteine concentration in the UK elderly population: | 01/11/2008 | Yes | No | |
| Results article | high-selenium yeast on plasma lipids results | 17/05/2011 | Yes | No |
