An Immunonutritional Approach to the Prevention of Skin Cancer

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032343
• Other study ID #: AICR 08-0131
• Secondary ID: UKCRN 6873
• Status: Completed
• Phase: N/A
• First received: December 14, 2009
• Last updated: August 21, 2013
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: August 2013
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Dietary Supplement:
• Omega-3 PUFA
One capsule (4g omega-3 PUFA) daily for 3 months
• Gelatine
One capsule daily for 3 months

Locations

Country	Name	City	State
United Kingdom	Salford Royal NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of suppression of nickel-induced contact hypersensitivity	Measurement of the erythema of nickel-induced eczema using a reflectance instrument	3 months	No
Secondary	Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers		3 months	No
Secondary	Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio		3 months	No
Secondary	Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers		3 months	No

External Links

•   Study recruitment information