An Immunonutritional Approach to the Prevention of Skin Cancer

• ClinicalTrials.gov Identifier: NCT01032343
• Recruitment Status: Completed
• First Posted: December 15, 2009
• Last Update Posted: August 22, 2013
• Sponsor: University of Manchester
• Information provided by (Responsible Party): Lesley Rhodes, University of Manchester

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United Kingdom

Salford Royal NHS Foundation Trust

Manchester, United Kingdom, M6 8HD

Sponsors and Collaborators

University of Manchester

Investigators

• Principal Investigator: Lesley E Rhodes, MBBS, MD; University of Manchester

More Information

Additional Information:

Study recruitment information 

Publications of Results:

Pilkington SM, Massey KA, Bennett SP, Al-Aasswad NM, Roshdy K, Gibbs NK, Friedmann PS, Nicolaou A, Rhodes LE. Randomized controlled trial of oral omega-3 PUFA in solar-simulated radiation-induced suppression of human cutaneous immune responses. Am J Clin Nutr. 2013 Mar;97(3):646-52. doi: 10.3945/ajcn.112.049494. Epub 2013 Jan 30.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pilkington SM, Rhodes LE, Al-Aasswad NM, Massey KA, Nicolaou A. Impact of EPA ingestion on COX- and LOX-mediated eicosanoid synthesis in skin with and without a pro-inflammatory UVR challenge--report of a randomised controlled study in humans. Mol Nutr Food Res. 2014 Mar;58(3):580-90. doi: 10.1002/mnfr.201300405. Epub 2013 Dec 5.

• Responsible Party: Lesley Rhodes, Professor of Experimental Dermatology, University of Manchester
• ClinicalTrials.gov Identifier: NCT01032343
• Other Study ID Numbers: AICR 08-0131; UKCRN 6873 ( Registry Identifier: UK Clinical Research Network )
• First Posted: December 15, 2009
• Last Update Posted: August 22, 2013
• Last Verified: August 2013

Keywords provided by Lesley Rhodes, University of Manchester:

Immunosuppression; Ultraviolet radiation; Nickel; Contact hypersensitivity

Additional relevant MeSH terms:

Skin Neoplasms; Neoplasms by Site; Neoplasms; Skin Diseases