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Trial registered on ANZCTR


Registration number
ACTRN12608000180314
Ethics application status
Approved
Date submitted
5/04/2008
Date registered
9/04/2008
Date last updated
30/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Mepilex dressings on radiation-induced skin reactions in women with breast cancer
Scientific title
The effect of mepilex lite dressings on the management of radiation-induced skin reactions in women with breast cancer
Secondary ID [1] 288030 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation-induced skin reactions in women that receive radiation therapy for breast cancer. 2999 0
Condition category
Condition code
Skin 3150 3150 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mepilex Lite dressings consist of a thin flexible foam with silicon webbing which does not react with chemicals in and on the skin. The dressings will be used to cover parts of skin that shows signs of radiation-induced skin reactions (mild erythema). Progression from mild to severe erythema and to dry desquamation will be monitored and compared to parts of the irradiated skin that is treated with standard skin care (in-patient controls).
The dressings will be applied from the moment erythema is seen (usually 2 weeks into the 5 week treatment). They will be replaced weekly for the duration of the treatment and for four weeks after treatment has been completed.
Intervention code [1] 2742 0
Treatment: Other
Comparator / control treatment
Standard care for radiation-induced skin reactions in Dunedin Hospital is an emollient aquaous cream. The cream will be applied to the skin (topically) daily from the moment radiation treatment starts till 4 week after completion of treatment.
Control group
Active

Outcomes
Primary outcome [1] 4034 0
Slower progression from mild to severe erythema and lack of progression to dry desquamation in areas of skin that are covered with the dressing compared to standard treatment. Erythema will be assesses by a standard Radiation Induced Skin Reaction Assessment Scale (RISRAS) and by digital photographs (Canon, with customized setting and photoshop software)
Timepoint [1] 4034 0
Three times a week from the moment erythema is seen (usually in week 2 of treatment) till end of treatment (which is 5 weeks). Further time points are 1 week and 4 weeks after completion of treatment.
Secondary outcome [1] 6799 0
Mepliex Lite dressings decrease erythema by a cooling effect of the skin. This will be assessed by skin temperature measurements using a Derma Temp infrared surface skin scanner (Exergen).
Timepoint [1] 6799 0
Three times a week from the moment erythema is seen (usually in week 2 of treatment) till end of treatment (which is 5 weeks). Further time points are 1 week and 4 weeks after completion of treatment.

Eligibility
Key inclusion criteria
All women that are having radiation therapy for breast cancer and have not had a previous radical mastectomy at Dunedin Hospital;, Department of Oncology (Radiation Therapy)
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who have had a previous radical mastectomy are excluded from this trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patients act as their own controls. Parts of the skin that show erythema will be covered with dressings and part will receive standard care. If the dressings prove to stop progression to dry desquamation and the standard treatment does not, all affected skin areas will be covered by dressing. If there is an adverse reaction to the dressings, all skin will be treated with standard skin care.
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 858 0
New Zealand
State/province [1] 858 0
South Island, Dunedin

Funding & Sponsors
Funding source category [1] 3262 0
University
Name [1] 3262 0
University of Otago, Wellington
Address [1] 3262 0
Mein Street,
PO Box 7343
Wellington South
Country [1] 3262 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Wellington
Address
Mein Street,
PO Box 7343
Wellington South
Country
New Zealand
Secondary sponsor category [1] 2927 0
Hospital
Name [1] 2927 0
Otago Distric Health Board (Dunedin Hospital
Address [1] 2927 0
201 Great King Street
PO Box 1921
Dunedin
Country [1] 2927 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5258 0
Lower South Island Ethics Committee
Ethics committee address [1] 5258 0
229 Morray Place
PO Box 5849
Dunedin
Ethics committee country [1] 5258 0
New Zealand
Date submitted for ethics approval [1] 5258 0
31/03/2008
Approval date [1] 5258 0
05/05/2008
Ethics approval number [1] 5258 0

Summary
Brief summary
Radiation therapy of the breast aims to eradicate all possible remaining tumour cells and, in addition, can cause skin reactions, varying from a slight reddening of the skin to itching, cracking, blistering or peeling, leaving the underlying tissues exposed. Although there are several ways to manage radiation-induced skin reactions, there is currently no standard protocol in New Zealand.

A promising new range of Swedish silicon-foam skin dressings, (Mepilex Lite, Molnlycke), is currently in use in many hospitals in New Zealand for the treatment of burns. This project aims to investigate the cooling effects of the dressings on radiation-induced skin reactions in 40 women undergoing radiation treatment for breast cancer in Dunedin Hospital. When reddening of the skin is seen, several parts of the irradiated breast area will be covered with dressings, whilst the other parts will be treated with a moisturizing cream. Skin condition will be assessed three times a week for the duration of treatment, as well as 1 and 4 weeks after treatment has been completed, using an established skin assessment scale, digital photographs and heat measurements.
Trial website
Trial related presentations / publications
Diggelmann, K.V., Zytkovicz, A.E., Tuaine, J.M., Bennett, N.C., Kelly, L.E., Herst, P.M. Mepilex Lite dressings for the management of radiation-induced erythema: a systematic inpatient controlled clinical trial. Br J Radiol. 83(995): 971-934 (2010).
Public notes
Attachments [1] 653 653 0 0

Contacts
Principal investigator
Name 28494 0
Dr Patries Herst
Address 28494 0
Department of radiation Therapy
University of Otago, Wellington
POBox 7343
Wellington South
Postcode 6242
Country 28494 0
New Zealand
Phone 28494 0
+64-4-3855475
Fax 28494 0
Email 28494 0
patries.herst@otago.ac.nz
Contact person for public queries
Name 11651 0
Mrs Noelle Bennett
Address 11651 0
Department of Oncology (Radiation Therapy)
Dunedin Hospital
201 Great King Street
PO Box 1921
Dunedin
Country 11651 0
New Zealand
Phone 11651 0
phone:+64-3-4747047
Fax 11651 0
fax:+64-3-4747656
Email 11651 0
noelle.bennett@otagodhb.govt.nz
Contact person for scientific queries
Name 2579 0
Dr Dr Patries Herst
Address 2579 0
Department of Radiation Therapy
University of Otago, Wellington
Mein Street
PO Box 7343
Wellington South 6242
Country 2579 0
New Zealand
Phone 2579 0
+64-4-3855475 ext 4753
Fax 2579 0
+64-4-3855375
Email 2579 0
patries.herst@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary