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Trial registered on ANZCTR


Registration number
ACTRN12621000124831
Ethics application status
Approved
Date submitted
27/11/2020
Date registered
8/02/2021
Date last updated
8/02/2021
Date data sharing statement initially provided
8/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Mepitel Film vs StrataXRT Gel in managing radiation-induced skin reactions in chest wall patients
Scientific title
Mepitel Film vs StrataXRT Gel in managing radiation-induced skin reactions in chest wall patients
Secondary ID [1] 302885 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 319885 0
Acute radiation-induced skin reactions 320603 0
Condition category
Condition code
Skin 317821 317821 0 0
Other skin conditions
Cancer 318459 318459 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial will compare the effect on radiation-induced skin reactions of a new silicone product, StrataXRT. This is a silicone based gel that forms a thin transparent film once spread on the skin. The gel is thought to reduce the severity of skin reactions by protecting the irradiated skin from friction damage and create a moist wound healing environment.

StrataXRT Gel will be applied by the patient twice a day from day 1 of radiation therapy until 4 weeks after completion of treatment or until moist desquamation occurs, whichever comes first. The amount of gel applied will be a blob the size of a thumb nail. Patients will be asked by the research radiation therapist once a week whether or not they have been compliant.
Intervention code [1] 319170 0
Treatment: Devices
Comparator / control treatment
Mepitel Film will be our active control.. Mepitel Film is the current gold standard for managing radiation-induced skin reactions in breast cancer patients. Mepitel Film is a soft silicone breathable film and will be applied by the radiation therapist once a week from day 1 of radiation therapy until 4 weeks after completion of treatment or until moist desquamation occurs, whichever comes first.

Our patients will act as their own controls. They will get to experience both Mepitel Film and StrataXRT Gel. Only mastectomy patients will be recruited. The part of the chest wall to be irradiated will be divided into two equal halves. One half will be randomized to Mepitel Film and the other half will be randomized to StrataXRT.
Control group
Active

Outcomes
Primary outcome [1] 325843 0
Measure the whether or not moist desquamation has developed in skin patches covered in Film and Gel using the researcher component of RISRAS (Radiation Induced Skin Reaction Assessment Scale) and the expanded RTOG (Radiation Therapy and Oncology Group) grading system.

Both RISRAS and RTOG determine the presence and extent of moist desquamation in different ways.
Timepoint [1] 325843 0
The primary endpoint is whether or not moist desquamation has occurred by the end of the trial.
This will be assessed weekly from the start of the trial, with the primary endpoint occurring at the end of the trial (4 weeks after completion of treatment).
Secondary outcome [1] 389305 0
Measure the overall skin reaction severity in skin patches covered in each of the interventions using both the researcher and patient components of RISRAS and the expanded RTOG.

Both RISRAS and RTOG determine the severity of skin reactions in different ways.
Timepoint [1] 389305 0
Skin reaction severity will be measured once a week during radiation until 4 weeks after completion of radiation therapy.
Secondary outcome [2] 389306 0
To measure patient satisfaction with both interventions using an exit questionnaires that has been developed specifically for our skin trials.
Timepoint [2] 389306 0
The secondary time points will be all the weekly time points at which the skin reaction severity has been measured. Skin reactions will be scored weekly.
Secondary outcome [3] 389307 0
To do an in-depth cost analysis in the costs involved in using each intervention, both with respect to the direct cost of the product per patient and the indirect cost of radiation therapist/nursing time per patient.

Patient costs will be determined by the number of tubes of Gel or pieces of Film have been used and how much time was spent by nurses/radiation therapists in applying the Film.
Timepoint [3] 389307 0
At the end of the trial (4 weeks after completion of treatment).

Eligibility
Key inclusion criteria
All women aged 18 years and over receiving radiation for breast cancer after having had a mastectomy.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Distant metastatic disease
• Previous radiation to chest area
• Skin conditions that may aggravate RT-induced reactions
• Karnofsky score <70
• Not able to come to 4 follow up sessions

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)
At the start of radiation therapy, the chest area to be irradiated will be divided into a medial and lateral half (containing the axilla). The dividing line will be decided by drawing the field border on the skin on Day 1 of treatment and dividing this in half, using permanent markers. Each half will be randomised to either the Film or the Gel.

Randomisation will be stratified by radiation fractionation regime (26 Gy in 5 fractions, 40Gy in 15 fractions or 50Gy in 25 fractions) and per participating centre to ensure that allocation of Film and Gel over the different regimen and centres is even and to allow for subgroup analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done by the academic PI, Associate Professor Patries Herst from the University of Otago, Wellington, using computer generated random numbers, provided by the University’s biostatistician, Dr Robin Willink.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patients act as their own controls; they will experience the effects of both the Film and the Gel.
This will be an open label trial because the participants and radiation therapists/oncology nurses can see where the Film and Gel are on the chest wall. However, we will have an independent researcher familiar with the scoring systems, score both sides of the chest wall in the second week after completion of treatment to provide an unblinded score.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The aim of the trial is to determine if Gel is adequate compared with Film in decreasing the number of women who develop moist desquamation during or immediately after radiation for breast cancer. If (a) ‘adequate’ means that the probability of developing MD with the Gel is less than 0.075 more than the probability with the film and (b) the probability of declaring it adequate when it is actually inadequate is kept at or below the standard level alpha=5% (one-sided) and (c) the probability of developing MD with the Gel is actually 0.03 more than the probability with the film then (d) we need a minimum of 120 women to make the probability of declaring it adequate when it is adequate reach 71%. If we factor in a 20% drop-out rate, we would need 145 participants.

Baseline characteristics by treatment arm will be summarised in frequency tables and by the use of descriptive statistics for quantitative variables. Summary tables will be prepared giving numbers of patients by treatment arm and by randomisation irregularities, treatment compliance, eligibility infringements, and losses to follow-up (as per CONSORT guidelines).

Primary outcome: incidence of moist desquamation
Data are dichotomous: either there is moist desquamation or there is no moist desquamation. We will use standard statistical procedures to obtain confidence intervals for the differences in incidence between Film and Gel. We will use these intervals to conduct the standard hypothesis tests. We will use Fishers exact, Chi-square as appropriate.

Secondary outcomes
1. Overall skin reaction severity
Data for RISRAS are continuous and the data for the expanded RTOG grading system are categorical with 7 possible categories (0, 1, 1.5, 2, 2.5, 3, 4). We will use the non-parametric Wilcoxon signed ranks test for RISRAS scores and the Chi-squared test for expanded RTOG grades respectively to determine the statistical significance between differences in skin reaction severity in skin areas covered in Film and Gel.

2. Patient satisfaction: Exit questionnaires
We will perform a thematic content analysis of answers to the open questions of the exit questionnaires as well as a frequency analysis of Yes/No questions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2021
Actual
Date of last participant enrolment
Anticipated
1/02/2023
Actual
Date of last data collection
Anticipated
24/03/2023
Actual
Sample size
Target
145
Accrual to date
Final
Recruitment outside Australia
Country [1] 23229 0
New Zealand
State/province [1] 23229 0

Funding & Sponsors
Funding source category [1] 307303 0
University
Name [1] 307303 0
University of otago
Country [1] 307303 0
New Zealand
Funding source category [2] 307304 0
Hospital
Name [2] 307304 0
Christchurch Hospital
Country [2] 307304 0
New Zealand
Funding source category [3] 307305 0
Hospital
Name [3] 307305 0
St George"s Hospital
Country [3] 307305 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Molnlycke Healtcare LTD
Address
Box 130 80
Gamlestadsvägen 3C
SE-402 52
Gothenburg
Country
Sweden
Secondary sponsor category [1] 307943 0
Commercial sector/Industry
Name [1] 307943 0
Stratpharma AG
Address [1] 307943 0
Aeschenvorstadt 57
Basel-City
4051 CH
Country [1] 307943 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307400 0
University of Otago, Human Research Ethics Committee
Ethics committee address [1] 307400 0
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 307400 0
New Zealand
Date submitted for ethics approval [1] 307400 0
Approval date [1] 307400 0
26/11/2020
Ethics approval number [1] 307400 0
H20/130

Summary
Brief summary
Background
Breast cancer is the most common malignancy for women in New Zealand. Radiation-induced skin reactions occur in 80-90% of breast cancer patients by completion of treatment and can severely affect patient comfort levels.

We have shown that using Mepitel Film on the irradiated skin significantly decreases skin reaction severity by creating a moist healing environment and preventing friction between damaged skin and clothing or other body parts of the irradiated skin. This allows for repair of the fragile skin rather than exacerbating the damage.

One of the negative aspects of Mepitel Film is that it needs to be applied very carefully by a radiation therapist or an oncology nurse once a week or more often in some patients, which takes up valuable staff resources.

StrataXRT Gel is a silicone gel product that forms a thin silicone film when rubbed onto the skin, presumably with similar protective properties. Gel is applied by the patients themselves twice a day, requiring fewer hospital resources.

In this RCT we want to find out if Gel is adequate compared with Film in decreasing the number of women who develop moist desquamation during or immediately after radiation for breast cancer.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107098 0
A/Prof Patries Herst
Address 107098 0
Department of Radiation Therapy
University of Otago,
Wellington

POBox 7343
Wellington South 6242
Country 107098 0
New Zealand
Phone 107098 0
+6443855475
Fax 107098 0
Email 107098 0
[email protected]
Contact person for public queries
Name 107099 0
Patries Herst
Address 107099 0
Department of Radiation Therapy
University of Otago,
Wellington

POBox 7343
Wellington South 6242
Country 107099 0
New Zealand
Phone 107099 0
+6443855475
Fax 107099 0
Email 107099 0
[email protected]
Contact person for scientific queries
Name 107100 0
Patries Herst
Address 107100 0
Department of Radiation Therapy
University of Otago,
Wellington

POBox 7343
Wellington South 6242
Country 107100 0
New Zealand
Phone 107100 0
+6443855475
Fax 107100 0
Email 107100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified RISRAS and TROG data of individual patients that is used for the final analysis.
When will data be available (start and end dates)?
After publication until 10 years after publication.
Available to whom?
Other researchers in the field upon request
Available for what types of analyses?
Analysis of skin reaction severity using average RISRAS and maximum RTOG
How or where can data be obtained?
De-identified data will be made available in spread sheets from the principal Investigator upon request by email.

[email protected]


What supporting documents are/will be available?




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.