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 (NCT)	NCT01032343
Protocol serial number	N/A
Sponsor	University of Manchester (UK)
Funder	Association for International Cancer Research (AICR) (UK) (ref: 08-0131)

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

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

Study information

Primary study design	Interventional
Study design	Single centre, double-blind, randomised, placebo controlled nutritional study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

Photobiology Unit

Manchester
M6 8HD
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	results	01/03/2013		Yes	No
Results article	results	01/03/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/04/2018: Publication references added.