Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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: August 21, 2013
Last verified: August 2013
History of Changes
  Purpose
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 Intervention
Skin Cancer
 Dietary Supplement: Omega-3 PUFA
Dietary Supplement: Gelatine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression

Resource links provided by NLM:

MedlinePlus related topics: Skin Cancer
U.S. FDA Resources

Further study details as provided by University of Manchester:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]
Enrollment: 90
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01032343

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  This link exits the ClinicalTrials.gov site

Publications:

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

Responsible Party: Lesley Rhodes, Professor of Experimental Dermatology, University of Manchester
ClinicalTrials.gov Identifier: NCT01032343     History of Changes
Other Study ID Numbers: AICR 08-0131  UKCRN 6873 
Study First Received: December 14, 2009
Last Updated: August 21, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Manchester:
Immunosuppression
Ultraviolet radiation
Nickel
Contact hypersensitivity

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on September 28, 2016