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Trial registered on ANZCTR


Registration number
ACTRN12612000949886
Ethics application status
Approved
Date submitted
5/09/2012
Date registered
5/09/2012
Date last updated
25/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Mepitel Film for the prevention of skin ulceration caused by radiation therapy in breast cancer patients.
Scientific title
The efficacy of Mepitel Film in preventing radiation-induced moist desquamation in breast cancer patients.
Secondary ID [1] 281168 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer patients treated with radiation 287334 0
Acute side effects of radiation therapy for breast cancer 287335 0
Condition category
Condition code
Cancer 287671 287671 0 0
Breast
Skin 287672 287672 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who are to be treated with radiation therapy for breast cancer will be invited to particiate in this trial.
At the start of radiation treatment the chest area to be irradiated will be divided into a medial and lateral half (containing the axilla). Each half will be randomized to either the treatment or the control arm.

Treatment Arm
1. Mepitel Film will be placed on the skin area randomized to the treatment arm by the research radiation therapist. Film will be replaced when necessary (approximately every 1 or 2 weeks).
2. Radiation therapy will be given through the Film, due to the extremely small bolus effect.
3. The Film will remain in place for the duration of RT treatment and after completion of radiation therapy treatment until the skin reactions resolve fully.

Control Arm
1. Aqueous cream will be applied by the patient twice a day to treat the control skin areas.

Trial Endpoint: moist desquamation
When moist desquamation occurs in either the Mepitel Film or control patches, the skin will be treated as per department protocol.
Intervention code [1] 285617 0
Prevention
Comparator / control treatment
Aqueous cream will be applied by the patient twice a day to treat the control skin areas for the entire duration of the trial (from the first day of treatment till resolution of all skin reactions).
Control group
Active

Outcomes
Primary outcome [1] 287914 0
Incidence of moist desquamation. Moist desquamation is when the integrity of the epidermis is lost, leading to ulceration. We will use the RISRAS scale to assess all skin reactions, including moist desquamation. This Radiation-Induced Skin Reaction Assessment Scale was developed specifically for these situations by Noble Adams (Br J Nurs. 1999 Nov;8(19):1305-12) and later adjusted by McBride et al. (Cancer Nurs. 2008 Jan-Feb;31(1):E8-14).We have used this scale in our previous two trials (Diggelmann et al. BJR, 83 (2010), 971?978).
Timepoint [1] 287914 0
The number of skin patches in the treatment and control arms that develop moist desquamation during the trial.
The trial commences at the time that the patients will get their very first radiation therapy treatment. Treatment usually lasts 5 weeks. Patients will continue to be seen once a week for four weeks after completion of treatment or untill all skin reactions have been resolved.
Secondary outcome [1] 299046 0
Time to developing moist desquamation. Moist desquamation will be assessed under primary outcome 1.
Timepoint [1] 299046 0
The number of days it takes to develop moist desquamation in skin patches in the treatment and control arms after commencement of radiation treatment.
Secondary outcome [2] 301101 0
The severity of the skin reactions which will be determined by RISRAS.
Timepoint [2] 301101 0
RISRAS scores will be determined three times a week during treatment and once a week after completion of treatment until skin reacyions resolve (usually 4-6 weeks after treatment completion)

Eligibility
Key inclusion criteria
Patients who receive radiation therapy for breast cancer.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous radiation therapy to the chest
Metastatic disease
Inability to attend follow up sessions

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Patients will commence RT treatment after having received information about the trial verbally from the radiation oncologist and research radiation therapist and in the form of the participant information sheet. They will also give written informed consent .
2. At the start of treatment the chest area to be irradiated will be divided into a medial and lateral half (containing the axilla). Each half will be randomized to either the treatment or the control arm.
3. Randomization will be done by the PI, Dr Patries Herst from the University of Otago, Wellington, using computer generated random numbers, provided by the University’s biostatistician, Dr James Stanley.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients will act as their own controls. This circumvents confounding patient-related and treatment-related factors. Randomization will circumvent the effect of small dose differences between the areas with dressings and the areas without dressings. In addition, TLDs will be used on all patients to determine the actual dose received by skin areas covered in Film and those treated with aqueous cream.
Phase
Phase 3
Type of endpoint(s)
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] 4533 0
New Zealand
State/province [1] 4533 0
South Island, Dunedin

Funding & Sponsors
Funding source category [1] 285942 0
Commercial sector/Industry
Name [1] 285942 0
Molnlycke Healthcare Ltd
Address [1] 285942 0
Molnlycke Healthcare
Box 130 80
SE-402 52 Gothenburg
Sweden
Country [1] 285942 0
Sweden
Primary sponsor type
University
Name
University of Otago
Address
POBox 7343
Wellington South
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 284766 0
Hospital
Name [1] 284766 0
Dunedin Hospital
Address [1] 284766 0
Southern DHB
Private Bag 1921
Dunedin 9054
Country [1] 284766 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287974 0
University of Otago Human Ethics Committee
Ethics committee address [1] 287974 0
University of Otago
Academic Committees
PO Box 56,
Dunedin 9054,
New Zealand
Ethics committee country [1] 287974 0
New Zealand
Date submitted for ethics approval [1] 287974 0
04/09/2012
Approval date [1] 287974 0
24/10/2012
Ethics approval number [1] 287974 0
12/239

Summary
Brief summary
Breast cancer is the most common malignancy for women in New Zealand. Severe skin reactions occur in a significant proportion of women who receive radiation therapy for breast cancer. Skin ulceration affects patient quality of life and poses a risk of infection. There is currently no standard treatment for radiation-induced skin reactions.
We have shown in two trials in New Zealand that Mepilex Lite dressings decrease the severity of acute radiation-induced skin reactions. Both trials were intra-patient controlled randomized trials, whereby each patient acted as their own control, circumventing the problem of the many confounding treatment-and patient-related factors that affect the severity of such skin reactions.
However, the dressing were not transparent and did not stick well in the armpit and underneath the breast.
Mepitel Film has all the advantages of Mepilex Lite but is transparent, sticks better and stays on for longer. This study will compare the efficacy of Mepitel Film with that of aqueous cream in reducing the incidence of radiation-induced skin ulceration in 40 women treated for breast cancer.
Trial website
Trial related presentations / publications
The trial has recently been published:
Patries M Herst, Noelle C Bennett, Annie E Sutherland, Ruth I Peszynski, Dean B Paterson & Marieke L Jasperse. Prophylactic use of Mepitel Film prevents radiation-induced moist desquamation in an intra-patient randomised controlled clinical trial of 78 breast cancer patients. Radiotherapy and Oncology. 2014. 110(1) pp. 137-143).
Public notes

Contacts
Principal investigator
Name 34667 0
Dr Patries Herst
Address 34667 0
University of Otago POBox 7343 Wellington South Wellington 6242.
Country 34667 0
New Zealand
Phone 34667 0
+64 4 3855475
Fax 34667 0
+64 4 3855375
Email 34667 0
patries.herst@otago.ac.nz
Contact person for public queries
Name 17914 0
Dr Patries Herst
Address 17914 0
Radiation Therapy
Senior Lecturer
University of Otago
POBox 7343
Wellington South
Wellington 6242
Country 17914 0
New Zealand
Phone 17914 0
+64 4 3855475
Fax 17914 0
+64 4 3855375
Email 17914 0
patries.herst@otago.ac.nz
Contact person for scientific queries
Name 8842 0
Dr Patries Herst
Address 8842 0
Radiation Therapy
Senior Lecturer
University of Otago
POBox 7343
Wellington South
Wellington 6242
Country 8842 0
New Zealand
Phone 8842 0
+64 4 3855475
Fax 8842 0
+64 4 3855375
Email 8842 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