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An Immunonutritional Approach to the Prevention of Skin Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032343
First Posted: December 15, 2009
Last Update Posted: August 22, 2013
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.
Information provided by (Responsible Party):
Lesley Rhodes, University of Manchester
December 14, 2009
December 15, 2009
August 22, 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 ]
Measurement of the erythema of nickel-induced eczema using a reflectance instrument
Degree of clinical photoimmunosuppression [ Time Frame: 3 months ]
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 ]
  • Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio [ Time Frame: 3 months ]
  • Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers [ Time Frame: 3 months ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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

*   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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01032343
AICR 08-0131
UKCRN 6873 ( Registry Identifier: UK Clinical Research Network )
No
Not Provided
Not Provided
Lesley Rhodes, University of Manchester
University of Manchester
Not Provided
Principal Investigator: Lesley E Rhodes, MBBS, MD University of Manchester
University of Manchester
August 2013

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