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An Immunonutritional Approach to the Prevention of Skin Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01032343
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : August 22, 2013
Information provided by (Responsible Party):
Lesley Rhodes, 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.

Condition or disease Intervention/treatment Phase
Skin Cancer Dietary Supplement: Omega-3 PUFA Dietary Supplement: Gelatine Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression
Study Start Date : July 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01032343

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United Kingdom
Salford Royal NHS Foundation Trust
Manchester, United Kingdom, M6 8HD
Sponsors and Collaborators
University of Manchester
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Principal Investigator: Lesley E Rhodes, MBBS, MD University of Manchester
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lesley Rhodes, Professor of Experimental Dermatology, University of Manchester Identifier: NCT01032343    
Other Study ID Numbers: AICR 08-0131
UKCRN 6873 ( Registry Identifier: UK Clinical Research Network )
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: August 22, 2013
Last Verified: August 2013
Keywords provided by Lesley Rhodes, University of Manchester:
Ultraviolet radiation
Contact hypersensitivity
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Skin Diseases