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Completed

NCT Number: NCT01032343

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Salford Royal NHS Foundation Trust

Manchester, M6 8HD, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 PUFA

Dietary Supplement

One capsule (4g omega-3 PUFA) daily for 3 months

Gelatine

Dietary Supplement

One capsule daily for 3 months

Primary outcomes

  1. Degree of suppression of nickel-induced contact hypersensitivity

    Time frame: 3 months

    Measurement of the erythema of nickel-induced eczema using a reflectance instrument

Secondary outcomes

  1. Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers

    Time frame: 3 months

  2. Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio

    Time frame: 3 months

  3. Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 15, 2009
Registry last updated
Aug 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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