An Immunonutritional Approach to the Prevention of Skin Cancer

Not Applicable

Completed

• Conditions: Skin Cancer
• Interventions: Dietary Supplement: Omega-3 PUFA; Dietary Supplement: Gelatine

• Registration Number: NCT01032343
• Lead Sponsor: University of Manchester

Brief Summary

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

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:

1. UVR-induced suppression of clinical contact hypersensitivity (CHS) responses

2. UVR-induced modulation of epidermal Langerhans cell trafficking

3. UVR-induced modulation of levels of immunoregulatory mediators

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Primary Completion: 2010-07
• Study Completion: 2010-11
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-21
• Last Update Posted: 2013-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 PUFA capsule	Omega-3 PUFA	-
Gelatine capsule	Gelatine	-

Primary Outcome Measures

Name	Time	Method
Degree of suppression of nickel-induced contact hypersensitivity	3 months	Measurement of the erythema of nickel-induced eczema using a reflectance instrument

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Salford Royal NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom