An Immunonutritional Approach to the Prevention of Skin Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression|
- Degree of suppression of nickel-induced contact hypersensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]Measurement of the erythema of nickel-induced eczema using a reflectance instrument
- Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Omega-3 PUFA capsule||
Dietary Supplement: Omega-3 PUFA
One capsule (4g omega-3 PUFA) daily for 3 months
|Placebo Comparator: Gelatine capsule||
Dietary Supplement: Gelatine
One capsule daily for 3 months
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032343
|Salford Royal NHS Foundation Trust|
|Manchester, United Kingdom, M6 8HD|
|Principal Investigator:||Lesley E Rhodes, MBBS, MD||University of Manchester|