Skin CancerNCT01032343
An Immunonutritional Approach to the Prevention of Skin Cancer
A study testing Omega-3 PUFA and Gelatine in people with Skin Cancer, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Omega-3 PUFA and Gelatine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2008to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pre-menopausal females
- Sun-reactive skin type I / II
- Reporting allergy to jewellery with nickel content
Who cannot join
- 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
Show all 9Show fewer
- Taking photoactive medicine
- Not able to eat fish or gelatine
- Taking fish oil supplements prior to the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal NHS Foundation Trust
Manchester, M6 8HD
About this study
Official title: 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.
Read the 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
- Conditions
- Skin Cancer
- Being tested
- Omega-3 PUFA, Gelatine
- Keywords
- Immunosuppression, Ultraviolet radiation, Nickel, Contact hypersensitivity
- Medical subject headings
- Skin Neoplasms, Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 PUFADietary supplement
One capsule (4g omega-3 PUFA) daily for 3 months
GelatineDietary supplement
One capsule daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 PUFA capsule | Active comparator | Not described Receives: Dietary Supplement: Omega-3 PUFA |
| Gelatine capsule | Placebo comparator | Not described Receives: Dietary Supplement: Gelatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of suppression of nickel-induced contact hypersensitivity
Measurement of the erythema of nickel-induced eczema using a reflectance instrument
Measured: 3 months
Secondary outcomes (3)
Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers
Measured: 3 months
Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio
Measured: 3 months
Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lesley Rhodes, University of Manchester
- Investigators
- Lesley E Rhodes, MBBS, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032343
- Sponsor's protocol ID
- AICR 08-0131
- Other IDs
- UKCRN 6873
- Status last verified
- Aug 2013
- First submitted
- 14 Dec 2009
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23364005Pilkington 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.
PubMed 24311515
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression
- ClinicalTrials.gov ID
- NCT01032343
- Acronym / sponsor ID
- AICR 08-0131
- Conditions
- Skin Cancer
- Keywords
- Immunosuppression, Ultraviolet radiation, Nickel, Contact hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 PUFA capsule | Active comparator | Dietary Supplement: Omega-3 PUFA |
| Gelatine capsule | Placebo comparator | Dietary Supplement: Gelatine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pre-menopausal females
- Sun-reactive skin type I / II
- Reporting allergy to jewellery with nickel content
Key exclusion criteria (9 listed)
- History of atopy
- History of skin cancer
- History of a photosensitivity disorder
- Sunbathing (including sunbeds) in the last 3 months
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 PUFAOne capsule (4g omega-3 PUFA) daily for 3 months | Dietary supplement | Omega-3 PUFA capsule |
| GelatineOne capsule daily for 3 months | Dietary supplement | Gelatine capsule |
Primary outcome
Degree of suppression of nickel-induced contact hypersensitivity
Time frame: 3 months
Measurement of the erythema of nickel-induced eczema using a reflectance instrument
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
- Results publication: PubMed 23364005Pilkington 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.
- Derived from this study: PubMed 24311515Pilkington 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.
- Study recruitment informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley E Rhodes, MBBS, MD principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 PUFA and Gelatine in people with Skin Cancer, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of suppression of nickel-induced contact hypersensitivity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01032343, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2013.