Condition category
Cancer
Date applied
26/02/2009
Date assigned
17/03/2009
Last edited
23/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.manchester.ac.uk/medicine/dermatological

Contact information

Type

Scientific

Primary contact

Prof Lesley Elizabeth Rhodes

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01032343

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

North Manchester Research Ethics Committee gave approval on the 13th June 2008 (ref: 08/H1006/30)

Study design

Single centre, double-blind, randomised, placebo controlled nutritional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation

Primary outcome measures

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 trial start date

02/03/2009

Overall trial end date

31/08/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

64

Participant 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

Recruitment start date

02/03/2009

Recruitment end date

31/08/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Photobiology Unit
Manchester
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Karen Shaw
Head of Research Office
Christie Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 8795
karen.shaw@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Funders

Funder type

Charity

Funder name

Association for International Cancer Research (AICR) (UK) (ref: 08-0131)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a nutrition journal.

Intention to publish date

31/03/2013

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/03/2016: Publication reference added, verifying study status with principal investigator.