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Trial registered on ANZCTR


Registration number
ACTRN12611000718943
Ethics application status
Approved
Date submitted
8/07/2011
Date registered
11/07/2011
Date last updated
25/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Mepilex Lite dressings on skin reactions in breast cancer patients treated with radiation therapy after having had a mastectomy.
Scientific title
The efficacy of Mepilex Lite dressings on the management of radiation-induced moist desquamation in breast cancer patients treated with radiation therapy post-mastectomy
Secondary ID [1] 262598 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation-induced moist desquamation of the skin 257389 0
Breast Cancer 268296 0
Condition category
Condition code
Skin 257535 257535 0 0
Dermatological conditions
Cancer 268429 268429 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mepilex Lite dressings. These consist of a thin flexible foam layer with silicon webbing which does not react with chemicals in and on the skin. The silicon layer allows the dressings to adhere to healthy skin but not to open wounds. As soon as the skin shows signs of erythema, the red skin will be divided into two equal halves. The halves will be randomized to either Mepilex Lite or control cream by the PI Dr Patries Herst who has no direct invovement in the day to day running of the trial (based on computer-generated random numbers).

The dressings are applied to one half of the red skin (they adhere without the need for adhesives). Their position on the skin is indicated by black permanent marker pens. The dressings are removed for radiation treatment and during showering. careful instruction is given to patients how to handle the dressings to keep them in a clean place and how to reapply them after showering. The dressings are changed every 4 days but when moist desquamation occurs, they will be replaced daily. Dressings will be used until the skin reaction is completely resolved, which may be upt o 6 weeks after completion of radiation treatment.
Intervention code [1] 256496 0
Treatment: Other
Comparator / control treatment
Standard aqueous cream will be used on the other half of the red skin, This will be applied twice a day from the moment of redness till either the end of the trial (up to 6 weeks after completion of radiation) or until moist desquamation occurs. If moist desquamation occures, these patches will be covered by the standard dressing that is used in each department.
Control group
Active

Outcomes
Primary outcome [1] 258447 0
Incidence of moist desquamation (the number of skin patches developing moist desquamation in areas covered in Mepilex Lite dressings divided by that in areas treated with aqueous cream).
The RISRAS (Radiation Induced Skin Reaction Assessment Scale) is used to assess the presence and extent of moist desquamation.
Timepoint [1] 258447 0
End of trial which is when there is complete resolution of the skin reactions (this can be up to 6 weeks after completion of radiation treatment.)
Secondary outcome [1] 264235 0
Time to onset of moist desquamation (the average time for developing moist desquamation in areas covered in Mepilex Lite dressings divided by that in areas treated with aqueous cream)
Timepoint [1] 264235 0
Time to moist desquamation
Secondary outcome [2] 264236 0
Time to healing (the average time to healing of areas covered in Mepilex Lite dressings divided by that of areas treated with standard dressing).

When the skinreactions have resolved completely; in the case of moist desquamation this means that there is new pink skin that covers the entire area.
Timepoint [2] 264236 0
Time to complete resolution of skin reactions

Eligibility
Key inclusion criteria
All women receiving post-mastectomy radiation therapy for breast cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with previous RT or systemic disease are excluded. Women who are unable to come back to the department for more skin assessments once a week after treatment has been completed until the final check-up at 6 weeks are also excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential particpants will be given information about the trial initially by their radiation oncologist, with more information provided by the research assistant at the time of the Computed Tomography (CT) planning scan. Written informed consent will be obtained before radiation therapy treatment commences. Participants will start radiation therapy treatment. At the first sign of erythema (redness) of the skin, this skin area will be divided into two equal halves. One half will be covered in Mepiilex Lite dressings, the other half will be treated with standard aqueous cream.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients act as their own controls. Comparison will be between two patches of skin on the same patient. Allocation of Mepilex Lite dressings and Aqueous cream will be randomized using computer generated random numbers produced by biostatistician and that are held by the PI who is an academic at the University of Otago, Wellington and is not directly involved in teh running of the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will act as their own controls. Once erythema develops on the chest wall, this area will be divided into two equal parts. One part will be randomly assigned to the Mepilex Lite arm and the other half will be treated with aqueous cream. Randomization will be based on computer generated random numbers that are held in the central trial centre.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/04/2011
Actual
12/04/2011
Date of last participant enrolment
Anticipated
12/04/2012
Actual
24/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 2633 0
New Zealand
State/province [1] 2633 0

Funding & Sponsors
Funding source category [1] 256985 0
University
Name [1] 256985 0
University of Otago
Country [1] 256985 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Molnlycke Healthcare LTD
Address
PO Box 130 80
SE-402 52 GOTEBORG
Country
Sweden
Secondary sponsor category [1] 256246 0
Hospital
Name [1] 256246 0
Wellington Regional Hospital
Address [1] 256246 0
Blood and Cancer Centre
Private bag 7902
Wellington 6242
New Zealand
Country [1] 256246 0
New Zealand
Secondary sponsor category [2] 256247 0
Hospital
Name [2] 256247 0
Dunedin Regional Hospital
Address [2] 256247 0
Southern Blood and Cancer Services
Private bag 1921
Dunedin 9016
Country [2] 256247 0
New Zealand
Secondary sponsor category [3] 256248 0
Hospital
Name [3] 256248 0
Auckland Radiation Oncology
Address [3] 256248 0
98 Mountain Rd
Epsom
Auckland 1023
Country [3] 256248 0
New Zealand
Secondary sponsor category [4] 256249 0
Hospital
Name [4] 256249 0
Palmerston North Regional Hospital
Address [4] 256249 0
Regional Cancer Treatment Service
Private bag 11036
Palmerston North 4442
Country [4] 256249 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258994 0
Multi-region Ethics Committee
Ethics committee address [1] 258994 0
Ethics committee country [1] 258994 0
New Zealand
Date submitted for ethics approval [1] 258994 0
Approval date [1] 258994 0
20/04/2010
Ethics approval number [1] 258994 0
MEC/10/04/033

Summary
Brief summary
Breast cancer is the most common malignancy for women in New Zealand; most will receive radiation therapy treatment. Skin reactions occur in 80-90% of patients and these can vary from redness to blistering or peeling (ulceration). To date, there is no standard treatment for radiation-induced skin reactions.

In a previous pilot study involving 30 women treated with radiation for breast cancer, we showed that Mepilex Lite dressings (a new Swedish silicon-foam skin dressing) were superior to a standard aqueous cream in decreasing redness of the skin. This current trial aims to investigate the effect of the dressings on ulceration in 80 women undergoing radiation treatment for breast cancer after mastectomy in public hospitals in Dunedin, Palmerston North, Wellington and in the Auckland Radiation Oncology private Centre. As soon as the skin turns red, the affected skin area will be randomly divided into two similar halves; one half will be covered in dressings, the other half will be treated with standard moisturising cream. Skin condition will be assessed three times a week for the duration of treatment, as well as once a week after treatment until complete resolution of the skin reactions, using an established skin assessment scale (RISRAS). (ACTRN12608000180314)
Trial website
Trial related presentations / publications
Paterson DB, Poonam P, Bennett NC, Peszynski RI, Van Beekhuizen MJ, Jasperse ML, Herst PM. (2012) Randomized Intra-patient Controlled Trial of Mepilex Lite Dressings versus Aqueous Cream in Managing Radiation-Induced Skin Reactions Post-mastectomy. J Cancer Sci Ther 4: 347-356.
Public notes
Attachments [1] 647 647 0 0
/AnzctrAttachments/335496-Paterson, 2012.pdf

Contacts
Principal investigator
Name 31175 0
Dr Patries Herst
Address 31175 0
Department of Radiation Therapy University of Otago, Wellington POBox 7343 Wellington South 6242
Country 31175 0
New Zealand
Phone 31175 0
+64-4-3855475
Fax 31175 0
+64-4-3855375
Email 31175 0
[email protected]
Contact person for public queries
Name 14422 0
Dr Patries Herst
Address 14422 0
Senior Lecturer
Department of Radiation Therapy
University of Otago, Wellington
POBox 7343
Wellington South 6242
Country 14422 0
New Zealand
Phone 14422 0
+64-4-3855475
Fax 14422 0
+64-4-3855375
Email 14422 0
[email protected]
Contact person for scientific queries
Name 5350 0
Dr Patries Herst
Address 5350 0
Senior Lecturer
Department of Radiation Therapy
University of Otago, Wellington
POBox 7343
Wellington South 6242
Country 5350 0
New Zealand
Phone 5350 0
+64-4-3855475
Fax 5350 0
+64-4-3855375
Email 5350 0
[email protected]

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