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Trial registered on ANZCTR


Registration number
ACTRN12619001477112
Ethics application status
Not required
Date submitted
4/10/2019
Date registered
25/10/2019
Date last updated
25/10/2019
Date data sharing statement initially provided
25/10/2019
Date results information initially provided
25/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
StrataXRT versus Mepitel film for radiation-induced dermatitis in patients receiving post-mastectomy radiotherapy for breast cancer
Scientific title
StrataXRT versus Mepitel film for radiation-induced dermatitis in patients receiving post-mastectomy radiotherapy for breast cancer: A randomised, non-inferiority, non-blinded, clinical trial.
Secondary ID [1] 290975 0
STRAT01
Universal Trial Number (UTN)
U1111-1191-8454
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 301728 0
Condition category
Condition code
Cancer 301424 301424 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
StrataXRT versus Mepitel film for radiation-induced dermatitis in patients receiving post-mastectomy radiotherapy for breast cancer.
The purpose of this study is to determine is StrataXRT as good as Mepitel Film in reducing the severity and duration of dermatitis caused by post-mastectomy radiotherapy for breast cancer.
Mepitel Film is a thin, transparent, breathable film which is applied to the skin as a dressing.
StrataXRT is a self-drying, non-sticky, transparent, silicone gel formulation that forms a film and lightly bonds to the most superficial skin layer.
In order to compare these two treatments we want to test both of them on each patient. Once a patient agrees to enter the trial and is registered, she will be randomly allocated to have Mepitel Film applied to either the lateral (outer) or medial (inner) half of the irradiated area of the chest wall. Mepitel Film will be applied by a nurse at the commencement of radiotherapy and re-applied every 1 – 2 weeks as required during and after radiotherapy until any dermatitis is resolved. StrataXRT will be applied by the patient to the other half of the irradiated area daily throughout radiotherapy and afterwards until any dermatitis is resolved.
Duration of intervention will be approximately 10 weeks. Adherence to the intervention will be monitored by clinical nurses by direct observation as well as patient feedback.
Intervention code [1] 315730 0
Treatment: Devices
Intervention code [2] 315818 0
Prevention
Comparator / control treatment
StrataXRT is the comparator
Control group
Active

Outcomes
Primary outcome [1] 321595 0
Time-weighted average grade of dermatitis will be calculated by multiplying the number of days between consecutive assessments by the average grade of the two assessments bounding each interval. The sum over all intervals will be divided by the total number of days from commencing radiotherapy to the last assessment or 10 weeks, whichever is earlier. If the patient ceases assessments before 10 weeks and the grades on the last assessment are 0, the grades will be assumed to be 0 for the rest of the time up to 10 weeks.
Timepoint [1] 321595 0
10 weeks from commencement of radiotherapy
Secondary outcome [1] 375507 0
Worst grade of radiation-induced dermatitis within 10 weeks- patient reported and clinical assesment
Timepoint [1] 375507 0
10 weeks from start of radiation treatment-
assessment will be weekly
Secondary outcome [2] 375901 0
Occurrence of moist desquamation- patient reported and clinical assesment
Timepoint [2] 375901 0
10 weeks from start of radiation treatment-
assessment will be weekly
Secondary outcome [3] 375903 0
Patient preference for either product- patient reported
Timepoint [3] 375903 0
10 weeks from start of radiation treatment-
assessment will be weekly
Secondary outcome [4] 375904 0
Feasibility and compliance with applications of both products(composite secondary)- patient reported and clinical assessment
Timepoint [4] 375904 0
10 weeks from start of radiation treatment-
assessment will be weekly

Eligibility
Key inclusion criteria
Histologically confirmed breast cancer.
Recent mastectomy.
Suitable for post-mastectomy chest wall and nodal radiotherapy.
Able and willing to comply with daily treatments and weekly assessments up to 10 weeks from commencement of radiotherapy
Age at least 18 years.
Has given written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to radiotherapy, eg ataxia, telangiectasia.
Prior radiotherapy to the breast
Skin which is unsuitable for application of Mepitel Film or StrataXRT.
Not medically competent to provide informed consent.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Treating clinician selects which products are applied to halves of 'the irradiated area of the chest wall
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Non-inferiority analysis on the “per protocol” population.
Upper limit of 2-sided 95% confidence interval for treatment effect (StrataXRT – Mepitel Film) adjusted for location effect (lateral – medial) in 5 x 10 cm rectangle in each area, and the whole areas, for:
• Time-weighted average grade of dermatitis
• Worst grade of dermatitis
• Incidence of moist desquamation
Proportion of patients preferring either treatment.
Comparison of treatments in “intention-to-treat” population, if non-inferiority is not shown.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/01/2017
Date of last participant enrolment
Anticipated
Actual
10/10/2017
Date of last data collection
Anticipated
Actual
30/06/2018
Sample size
Target
40
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 28198 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 303976 0
Commercial sector/Industry
Name [1] 303976 0
Genesis Cancer Care
Country [1] 303976 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Genesis Cancer Care
Address
Level 5, 126 Wellington Parade
East Melbourne
VIC 3002
Country
Australia
Secondary sponsor category [1] 304148 0
None
Name [1] 304148 0
Address [1] 304148 0
Country [1] 304148 0

Ethics approval
Ethics application status
Not required

Summary
Brief summary
This is a randomized, non-inferiority, non-blinded, clinical trial with the two treatments StrataXRT and Mepitel Film being compared within each patient. The purpose of this trial is to determine if StrataXRT is as good as Mepitel Film in reducing the severity and duration of radiation-induced dermatitis,
Trial website
Trial related presentations / publications
Public notes
Project was submitted for review by the Genesis National Oncology Research Committee (GNORC) as a Low and Negligible Risk project and was approved 8th November 2016

Contacts
Principal investigator
Name 71882 0
Dr Michael Chao
Address 71882 0
GenesisCare Ringwood
36 Mount Dandenong Road, Ringwood East Victoria 3135
Country 71882 0
Australia
Phone 71882 0
+61 3 8870 3300
Fax 71882 0
Email 71882 0
[email protected]
Contact person for public queries
Name 71883 0
Mrs Tenille Baker
Address 71883 0
GenesisCare
Level5, 126 Wellington Parade
East Melbourne
VIC 3002
Country 71883 0
Australia
Phone 71883 0
+61 0409 642 255
Fax 71883 0
Email 71883 0
[email protected]
Contact person for scientific queries
Name 71884 0
Dr Michael Chao
Address 71884 0
GenesisCare Ringwood
36 Mount Dandenong Road, Ringwood East Victoria 3135
Country 71884 0
Australia
Phone 71884 0
+61 3 8870 3300
Fax 71884 0
Email 71884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5212Statistical analysis plan  [email protected]



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.