- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01032343
An Immunonutritional Approach to the Prevention of Skin Cancer
The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Skin cancer is one of the most common human cancers with a rising incidence and considerable negative impact on human health. Exposure to ultraviolet radiation (UVR) in sunlight is the major aetiological factor in skin cancer initiation and progression. Human case-control studies have reported an inverse relationship between dietary fish or omega-3 polyunsaturated fatty acid (PUFA) intake and occurrence of non-melanoma skin cancer. Omega-3 PUFA have the potential to reduce the risk of photocarcinogenesis primarily by their ability to reduce production of prostaglandin E2 and consequently photoimmunosuppression. To date, no studies have assessed the impact of omega-3 PUFA on skin photoimmunosuppression in humans.
OBJECTIVE: To examine the potential of dietary omega-3 PUFA to protect against UVR-induced cutaneous immunosuppression in humans.
STUDY DESIGN: A double-blind randomised controlled nutritional study in 64 healthy human volunteers with nickel sensitivity. Volunteers will receive 3 months dietary supplementation with either omega-3 PUFA (n=32) or gelatine (n=32) both provided in identical gelatine capsules.
The aim is to quantify the influence of omega-3 PUFA on:
- UVR-induced suppression of clinical contact hypersensitivity (CHS) responses
- UVR-induced modulation of epidermal Langerhans cell trafficking
- UVR-induced modulation of levels of immunoregulatory mediators
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Manchester, United Kingdom, M6 8HD
- Salford Royal NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pre-menopausal females
- Sun-reactive skin type I / II
- Reporting allergy to jewellery with nickel content
Exclusion Criteria:
- History of atopy
- History of skin cancer
- History of a photosensitivity disorder
- Sunbathing (including sunbeds) in the last 3 months
- Pregnancy
- History of cardiac disease
- Taking photoactive medicine
- Not able to eat fish or gelatine
- Taking fish oil supplements prior to the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Omega-3 PUFA capsule
|
One capsule (4g omega-3 PUFA) daily for 3 months
|
Placebo Comparator: Gelatine capsule
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One capsule daily for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of suppression of nickel-induced contact hypersensitivity
Time Frame: 3 months
|
Measurement of the erythema of nickel-induced eczema using a reflectance instrument
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers
Time Frame: 3 months
|
3 months
|
Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio
Time Frame: 3 months
|
3 months
|
Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Pilkington SM, Massey KA, Bennett SP, Al-Aasswad NM, Roshdy K, Gibbs NK, Friedmann PS, Nicolaou A, Rhodes LE. Randomized controlled trial of oral omega-3 PUFA in solar-simulated radiation-induced suppression of human cutaneous immune responses. Am J Clin Nutr. 2013 Mar;97(3):646-52. doi: 10.3945/ajcn.112.049494. Epub 2013 Jan 30.
- Pilkington SM, Rhodes LE, Al-Aasswad NM, Massey KA, Nicolaou A. Impact of EPA ingestion on COX- and LOX-mediated eicosanoid synthesis in skin with and without a pro-inflammatory UVR challenge--report of a randomised controlled study in humans. Mol Nutr Food Res. 2014 Mar;58(3):580-90. doi: 10.1002/mnfr.201300405. Epub 2013 Dec 5.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AICR 08-0131
- UKCRN 6873 (Registry Identifier: UK Clinical Research Network)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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