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An Immunonutritional Approach to the Prevention of Skin Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lesley Rhodes, University of Manchester
ClinicalTrials.gov Identifier:
NCT01032343
First received: December 14, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes

December 14, 2009
January 14, 2013
July 2008
July 2010   (final data collection date for primary outcome measure)
Degree of suppression of nickel-induced contact hypersensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Measurement of the erythema of nickel-induced eczema using a reflectance instrument
Degree of clinical photoimmunosuppression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01032343 on ClinicalTrials.gov Archive Site
  • Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Immunonutritional Approach to the Prevention of Skin Cancer
The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Skin Cancer
  • Dietary Supplement: Omega-3 PUFA
    One capsule (4g omega-3 PUFA) daily for 3 months
  • Dietary Supplement: Gelatine
    One capsule daily for 3 months
  • Active Comparator: Omega-3 PUFA capsule
    Intervention: Dietary Supplement: Omega-3 PUFA
  • Placebo Comparator: Gelatine capsule
    Intervention: Dietary Supplement: Gelatine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
November 2010
July 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01032343
AICR 08-0131, UKCRN 6873
No
Lesley Rhodes, University of Manchester
University of Manchester
Not Provided
Principal Investigator: Lesley E Rhodes, MBBS, MD University of Manchester
University of Manchester
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP