An Immunonutritional Approach to the Prevention of Skin C... | NCT01032343

Studies
An Immunonutritional Approach to the Prevention of Skin Cancer

NCT01032343

Sponsor

University of Manchester

Status

Completed

Last Update Posted

Aug 22, 2013Estimated

Enrollment

90Actual

Phase

Not Applicable

Conditions

Skin Cancer

Interventions

Omega-3 PUFA
Gelatine

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UKCRN 6873	Registry Identifier	UK Clinical Research Network

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jul 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Dec 14, 2009

First Submission Date that Met QC Criteria

Dec 14, 2009

First Posted Date

Dec 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2013

Last Update Posted Date

Aug 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lesley Rhodes, Professor of Experimental Dermatology, University of ManchesterPrincipal Investigator

Lead Sponsor

University of ManchesterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omega-3 PUFA capsule	Active Comparator		Dietary Supplement: Omega-3 PUFA
Gelatine capsule	Placebo Comparator		Dietary Supplement: Gelatine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3 PUFA	Dietary Supplement	One capsule (4g omega-3 PUFA) daily for 3 months	Omega-3 PUFA capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of suppression of nickel-induced contact hypersensitivity	Measurement of the erythema of nickel-induced eczema using a reflectance instrument	3 months

Secondary Outcomes

Measure	Description	Time Frame
Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers		3 months
Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lesley E Rhodes, MBBS, MD	University of Manchester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Salford Royal NHS Foundation Trust		Manchester		M6 8HD	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23364005	Result	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.
24311515

ID	Term
D012878	Skin Neoplasms
D003877	Dermatitis, Contact

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D004281	Docosahexaenoic Acids
D005780	Gelatin

ID	Term
D015525	Fatty Acids, Omega-3
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats