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

Study website

Contact information

Prof Lesley Elizabeth Rhodes
Scientific

Photobiology Unit
Dermatological Sciences
University of Manchester
Salford Royal NHS Foundation Trust
Stott Lane
Manchester
M6 8HD
United Kingdom

Study information

Study designSingle centre, double-blind, randomised, placebo controlled nutritional study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOral 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 objectivesExposure 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) studiedSkin cancer prevention
InterventionActive: 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 typeSupplement
Primary outcome measureTo 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 measuresLevels 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 date02/03/2009
Completion date31/08/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants64
Key inclusion criteria1. Female
2. Aged 18 - 60 years
3. Sun reactive skin type 1 or 2
4. Reporting allergy to jewellery with nickel content
Key exclusion criteria1. 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 enrolment02/03/2009
Date of final enrolment31/08/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Photobiology Unit
Manchester
M6 8HD
United Kingdom

Sponsor information

University of Manchester (UK)
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
Email karen.shaw@manchester.ac.uk
Website http://www.manchester.ac.uk/
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Charity

Association for International Cancer Research (AICR) (UK) (ref: 08-0131)
Private sector organisation / International organizations
Alternative name(s)
AICR
Location
United Kingdom

Results and Publications

Intention to publish date31/03/2013
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planPlanned 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.