An Immunonutritional Approach to the Prevention of Skin Cancer
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01032343 |
Recruitment Status :
Completed
First Posted : December 15, 2009
Last Update Posted : August 22, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Skin Cancer | Dietary Supplement: Omega-3 PUFA Dietary Supplement: Gelatine | Not Applicable |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | November 2010 |
Arm | Intervention/treatment |
---|---|
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 |
- Degree of suppression of nickel-induced contact hypersensitivity [ Time Frame: 3 months ]Measurement of the erythema of nickel-induced eczema using a reflectance instrument
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032343
United Kingdom | |
Salford Royal NHS Foundation Trust | |
Manchester, United Kingdom, M6 8HD |
Principal Investigator: | Lesley E Rhodes, MBBS, MD | University of Manchester |
Publications of Results:
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 |
Other Study ID Numbers: |
AICR 08-0131 UKCRN 6873 ( Registry Identifier: UK Clinical Research Network ) |
First Posted: | December 15, 2009 Key Record Dates |
Last Update Posted: | August 22, 2013 |
Last Verified: | August 2013 |
Immunosuppression Ultraviolet radiation Nickel Contact hypersensitivity |
Skin Neoplasms Neoplasms by Site Neoplasms Skin Diseases |