An Immunonutritional Approach to the Prevention of Skin Cancer

Study Overview
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Brief Summary
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Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the principal cause. Solar UVR can promote cancer development through its ability to suppress the immune system. The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced immunosuppression.

Detailed Description
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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

Official Title
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The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression

Conditions
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Skin Cancer

Intervention / Treatment
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* Dietary Supplement: Omega-3 PUFA
* Dietary Supplement: Gelatine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3 PUFA capsule<br> | Dietary Supplement: Omega-3 PUFA<br>* One capsule (4g omega-3 PUFA) daily for 3 months<br>|
| Placebo Comparator: Gelatine capsule<br> | Dietary Supplement: Gelatine<br>* One capsule daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of suppression of nickel-induced contact hypersensitivity | Measurement of the erythema of nickel-induced eczema using a reflectance instrument | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers |  | 3 months | 
| Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio |  | 3 months | 
| Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunosuppression, Ultraviolet radiation, Nickel, Contact hypersensitivity