Fish oil in nickel sensitivity: an immunonutritional approach to the prevention of skin cancer
| ISRCTN | ISRCTN29336462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29336462 |
| ClinicalTrials.gov number | NCT01032343 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/02/2009
- Registration date
- 17/03/2009
- Last edited
- 26/04/2018
- 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 Lesley Elizabeth Rhodes
Scientific
Scientific
Photobiology Unit
Dermatological Sciences
University of Manchester
Salford Royal NHS Foundation Trust
Stott Lane
Manchester
M6 8HD
United Kingdom
Study information
| Study design | Single centre, double-blind, randomised, placebo controlled nutritional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Oral omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation in ultraviolet radiation (UVR) induced cutaneous immunosuppression: a single site, double-blind, randomised, placebo controlled nutritional study |
| Study objectives | Exposure to ultraviolet radiation (UVR) is a major cause of skin cancer development and acts to initiate cancer as well as promoting tumour development through photo-immunosuppression. Protection against photo-immunosuppression of contact hypersensitivity (CHS) in experimental models has been shown to correlate with protection against photocarcinogenesis. Experimental models show that photo-immunosuppression, and consequently photocarcinogenesis, is reduced by dietary intervention with omega-3 polyunsaturated fatty acid (n-3 PUFA). However, this has not been directly explored in humans. Positive results from this study would lead to further research examining the influence of n-3 PUFA on skin cancer occurrence. We hypothesise that oral n-3 PUFA supplements will protect against UVR induced cutaneous immunosuppression in humans. |
| Ethics approval(s) | North Manchester Research Ethics Committee gave approval on the 13th June 2008 (ref: 08/H1006/30) |
| Health condition(s) or problem(s) studied | Skin cancer prevention |
| Intervention | Active: fish oil supplements rich in n-3 PUFAs (Incromega E7010 SR, Croda, UK); 5 x 1 g capsules to be taken with breakfast Control (placebo): medium chain triglyceride oil (GTCC, Croda, UK); 5 x 1 g capsules to be taken with breakfast For each volunteer, the duration of nutritional supplementation is 12 weeks; follow-up is 2 weeks. |
| Intervention type | Supplement |
| Primary outcome measure | To examine the protective effect of n-3 PUFA on: 1. UVR-induced suppression of clinical CHS responses using the International Contact Dermatitis Research Group (ICDRG) grading scale: No reaction (-) to extreme positive (+++) 2. UVR-induced modulation of immune cells (epidermal Langerhans cells) using immunohistochemistry of epidermal sheets Assessed simultaneously at 13 weeks. |
| Secondary outcome measures | Levels of immunoregulatory mediators in the skin using mass spectrometry analysis and Luminex analysis of cytokine expression in suction blister fluid. Assessed simultaneously at 13 weeks. |
| Overall study start date | 02/03/2009 |
| Completion date | 31/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 64 |
| Key inclusion criteria | 1. Female 2. Aged 18 - 60 years 3. Sun reactive skin type 1 or 2 4. Reporting allergy to jewellery with nickel content |
| Key exclusion criteria | 1. History of atopy 2. History of skin cancer 3. History of a photosensitivity disorder 4. Sunbathing in the past 3 months 5. Pregnancy 6. History of cardiac disease 7. Taking of photoactive medication 8. Not able to eat fish or gelatin 9. Taking fish oil supplements prior to the study 10. Consuming more than 3 meals containing oily fish per week |
| Date of first enrolment | 02/03/2009 |
| Date of final enrolment | 31/08/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Photobiology Unit
Manchester
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
c/o Karen Shaw
Head of Research Office
Christie Building
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 275 8795 |
|---|---|
| karen.shaw@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Charity
Association for International Cancer Research (AICR) (UK) (ref: 08-0131)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- AICR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2013 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a nutrition journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No |
Editorial Notes
26/04/2018: Publication references added.
