An Immunonutritional Approach to the Prevention of Skin Cancer
Primary Purpose
Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Omega-3 PUFA
Gelatine
Sponsored by
About this trial
This is an interventional prevention trial for Skin Cancer focused on measuring Immunosuppression, Ultraviolet radiation, Nickel, Contact hypersensitivity
Eligibility 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
Sites / Locations
- Salford Royal NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Omega-3 PUFA capsule
Gelatine capsule
Arm Description
Outcomes
Primary Outcome Measures
Degree of suppression of nickel-induced contact hypersensitivity
Measurement of the erythema of nickel-induced eczema using a reflectance instrument
Secondary Outcome Measures
Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers
Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio
Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers
Full Information
NCT ID
NCT01032343
First Posted
December 14, 2009
Last Updated
August 21, 2013
Sponsor
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT01032343
Brief Title
An Immunonutritional Approach to the Prevention of Skin Cancer
Official Title
The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Immunosuppression, Ultraviolet radiation, Nickel, Contact hypersensitivity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 PUFA capsule
Arm Type
Active Comparator
Arm Title
Gelatine capsule
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 PUFA
Intervention Description
One capsule (4g omega-3 PUFA) daily for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Gelatine
Intervention Description
One capsule daily for 3 months
Primary Outcome Measure Information:
Title
Degree of suppression of nickel-induced contact hypersensitivity
Description
Measurement of the erythema of nickel-induced eczema using a reflectance instrument
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers
Time Frame
3 months
Title
Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio
Time Frame
3 months
Title
Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley E Rhodes, MBBS, MD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salford Royal NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23364005
Citation
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.
Results Reference
result
PubMed Identifier
24311515
Citation
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.
Results Reference
derived
Links:
URL
http://www.staffnet.manchester.ac.uk/volunteering/display/index.htm?id=149716
Description
Study recruitment information
Learn more about this trial
An Immunonutritional Approach to the Prevention of Skin Cancer
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