Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000265370
Ethics application status
Not yet submitted
Date submitted
22/05/2008
Date registered
26/05/2008
Date last updated
26/05/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on the cutaneous toxicities in oncology patients on Epidermal Growth Factor Receptor inhibitors: skin physiology, clincial manifestations and quality of life.
Scientific title
Quantifying physiological skin changes and quality of life in oncology patients on epidermal growth factor receptor inhibitors (EGFRIs) compared to normal participants not on EGFRIs. Can physiological skin changes be used to quantify cutaneous toxicities and evaluate subclinical changes before overt disease in order to prevent and minimise these side effects.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous side effects on oncology patients on EGFRIs 3180 0
Condition category
Condition code
Skin 3340 3340 0 0
Normal skin development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A pilot study assessing physiological skin changes using transepidermal water loss (TEWL), skin pH, skin surface hydration, skin sebum levels, skin surface perfusion and microbiological swabs and culture in conjunction with clinical photography and the Dermatology Quality of Life Index (DQLI) in oncology patients on EGFRIs for a period of 3 months.
Intervention code [1] 2912 0
Not applicable
Comparator / control treatment
Patients from outpatients/wards that are not on EGFRIs will act as controls for a one-off measurement of TEWL, skin pH, skin surface hydration, skin sebum levels, skin surface perfusion and DQLI
Control group
Active

Outcomes
Primary outcome [1] 4228 0
transepidermal water loss using Tewameter
Timepoint [1] 4228 0
at baseline, day 3, day 6, day 9, week 2, week 3, week 4, week 6,week 8, week 10 and week 12
Primary outcome [2] 4229 0
skin pH, sebum and hydration using Derma Unit SSC3 (3 combined unit: Sebumeter/Corneometer/Skin-pH-Meter)
Timepoint [2] 4229 0
at baseline, day 3, day 6, day 9, week 2, week 3, week 4, week 6,week 8, week 10, week 12
Primary outcome [3] 4230 0
skin surface perfusion using laser perfusion doppler imager
Timepoint [3] 4230 0
at baseline, day 6, week 2, week 4 ,week 8 and week 12
Secondary outcome [1] 7143 0
clinical photography using a standard 5 megapixel digital camera
Timepoint [1] 7143 0
depend on onset and severity of skin side effects
Secondary outcome [2] 7144 0
microbiology swab and culture
Timepoint [2] 7144 0
depend on onset and severity of skin side effects
Secondary outcome [3] 7145 0
Dermatology Quality of Life Index (DQLI)
Timepoint [3] 7145 0
at baseline, week 2, week 4, week 8, week 12

Eligibility
Key inclusion criteria
Oncology patients about to start EGFRIs
male or female
aged 18 years or above
willing to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Younger than 18 years of age
severe underlying disease that may interfere with the testing or test results

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3416 0
Self funded/Unfunded
Name [1] 3416 0
Linda Wang
Country [1] 3416 0
Australia
Primary sponsor type
Individual
Name
Linda Wang
Address
Liverpool Hospital
Department of Dermatology
(UNSW clinical school)
45-47 Goulburn St, Liverpool 2170
Country
Australia
Secondary sponsor category [1] 3060 0
Individual
Name [1] 3060 0
Dr John Sullivan
Address [1] 3060 0
Liverpool Hospital
Department of Dermatology
(UNSW clinical school)
45-47 Goulburn St, Liverpool 2170
Country [1] 3060 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5439 0
Bellberry Limited
Ethics committee address [1] 5439 0
First Floor
71 Anzac Highway
Ashford SA 5035
Ethics committee country [1] 5439 0
Australia
Date submitted for ethics approval [1] 5439 0
28/05/2008
Approval date [1] 5439 0
Ethics approval number [1] 5439 0

Summary
Brief summary
Epidermal growth factor receptor inhibitors (EGFRIs) have been shown efficacy in the treatment of several cancers but despite their potential to be revolutionary therapeutic agents, they are commonly associated with undesirable skin side effects, some of which are chronic or have profound physical and psychosocial impact on patients. This study aims to assess physiological skin changes in patients on EGFRIs using transepidermal water loss (TEWL), skin pH, skin sebum levels, skin surface hydration and surface perfusion measurements in conjunction with microbiology swabs, clinical photography and the Dermatology Quality of Life Index (DQLI) in order to understand the pathophysiology of cutaneous side effects, better characterise these toxicities using a refined classification system and evaluate subclinical changes before overt disease in order to prevent and minimise cutaneous side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28609 0
Address 28609 0
Country 28609 0
Phone 28609 0
Fax 28609 0
Email 28609 0
Contact person for public queries
Name 11766 0
Linda Wang
Address 11766 0
Liverpool Hospital
Department of Dermatology
(UNSW clinical school)
45-47 Goulburn St, Liverpool 2170
mail to locked bag 7103
Country 11766 0
Australia
Phone 11766 0
0410556918
Fax 11766 0
98284639
Email 11766 0
[email protected]
Contact person for scientific queries
Name 2694 0
Linda Wang
Address 2694 0
Liverpool Hospital
Department of Dermatology
(UNSW clinical school)
45-47 Goulburn St, Liverpool 2170
mail to locked bag 7103
Country 2694 0
Australia
Phone 2694 0
0410556918
Fax 2694 0
98284639
Email 2694 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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