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Trial registered on ANZCTR


Registration number
ACTRN12619000753156
Ethics application status
Approved
Date submitted
1/05/2019
Date registered
21/05/2019
Date last updated
19/11/2023
Date data sharing statement initially provided
21/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two routinely used skin treatments for women with breast cancer undergoing radiation therapy
Scientific title
A cost-benefit analysis of two skin treatments (Mepitel Film vs Strata XRT gel) for women with breast cancer undergoing radiation therapy
Secondary ID [1] 298092 0
None
Universal Trial Number (UTN)
U1111-1232-5260
Trial acronym
CONCERTo
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 312605 0
Acute radiation therapy (RT) skin toxicity and management 312607 0
Condition category
Condition code
Cancer 311113 311113 0 0
Breast
Skin 311182 311182 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In many cases following mastectomy, women require post-mastectomy radiation therapy (PMRT). Radiation skin reactions (or radiation dermatitis) are common and expected side effects of radiation treatment. Radiotherapy (RT) centres routinely implement skin care management systems applied to patients receiving breast cancer radiotherapy with the aim of preventing or minimising radiation skin reactions. This project is a randomised evaluation study comparing two routinely used skin management interventions (Mepitel Film + Strata XRT gel); aiming to assess the difference in cost-benefit and effectiveness.

Post-mastectomy Radiation Therapy (PMRT):
Standard radiation treatment will be delivered in both intervention arms. The conventional dose of 50 Gray (Gy) at 2.0 Gy per fraction over 25 fractions will be used; daily fractionation will be delivered Monday - Friday, with 9-10 fractions delivered per fortnight.

Participants will be randomised to one of two treatments arms prior to the commencement of PMRT.

Arm 1: Mepitel Film
Mepitel Film is a protective film dressing. It protects fragile skin allowing it to heal undisturbed. It is applied onto the skin while patients are in the same position required for the delivery of radiation treatment.

Radiotherapy induced skin reaction prevention and management will involve the placement of Mepitel film onto skin in the radiation treatment fields, by Radiation Oncology Nursing Staff from Day 1 until 2 weeks after RT is completed. Mepitel Film is first applied on day one of RT, then reviewed at regular intervals though treatment, or sooner if the patient has concerns. The thin film may need to be replaced several times. Mepitel film will be applied in Radiation Therapy treatment facilities.

Participants will see a Radiation Oncology Nurse on the first day of radiotherapy treatment who will explain Mepitel Film application and review the expected skin changes / skin care during treatment with the patient.
Intervention use will be monitored by nursing/medical staff incorporating documentation of the following assessments:
* Acute Toxicity Assessment of symptoms, skin appearance and other tissues
* Breast photo
* Nursing staff time evaluation of skin care intervention
* Skin management assessment (intervention application)

Arm 2: StrataXRT
StrataXRT is a flexible wound dressing routinely used for the prevention and treatment of radiation skin reactions or radiation dermatitis. It is a self-drying transparent gel that forms a protective waterproof layer which hydrates and protects skin. It is a unique formulation that requires substantially less product per application than typical moisturising creams.

Radiotherapy induced skin reaction prevention and management will involve a pea-sized amount of StrataXRT gel to be applied by the patient to the area being treated with radiation twice daily, from Day 1 until 2 weeks after RT is completed. Patients are reviewed once a week, or sooner if the patient has concerns.

Participants will see a Radiation Oncology Nurse on the first day of radiotherapy treatment, who will instruct patients on how to apply StrataXRT and review the expected skin changes / skin care during treatment with them. The nurse will be available to guide participants with gel application throughout treatment as much as is required.
Intervention compliance will be monitored by nursing/medical staff incorporating documentation of the following assessments:
* Acute Toxicity Assessment of symptoms, skin appearance and other tissues
* Breast photo
* Nursing staff time evaluation of skin care intervention
* Skin management assessment (intervention application)
Intervention code [1] 314323 0
Treatment: Devices
Intervention code [2] 314365 0
Treatment: Other
Comparator / control treatment
This project is a randomised evaluation study comparing two routinely used skin care management devices (Mepitel Film and Strata XRT). Participants will be randomised to receive one of two interventions as described above.
Control group
Active

Outcomes
Primary outcome [1] 319891 0
Difference in the cost of resources used (application of treatment for acute PMRT toxicity prevention and treatment, dressings and nursing time).

Health care professionals – time:
Time will be recorded in minutes for the direct care given to the skin, including the application of Mepitel dressings, StrataXRT or management of moist desquamation.

Costs - consumables required for skin care, minimisation and management of acute skin toxicity
* Each day the patient is reviewed, items involved with the above will be tallied
* The list of these items to be recorded include but are not limited to gloves, dressings, creams, StrataXRT, Mepitel dressings
* The specific costs in AUD, will be calculated centrally by the research team after data are entered into the ECRF:

A trial-specific paper flow-sheet will be provided to sites for the documentation of resource use/time during and after treatment.

Timepoint [1] 319891 0
*Pre radiotherapy
* A minimum of weekly during PMRT
* post PMRT (week 1 and week 2)
* where applicable weekly until side effects resolved
* week 6 post-PMRT.
Secondary outcome [1] 369811 0
Acute PMRT skin toxicity

A trial-specific paper flow-sheet will be completed by clinicians documenting skin toxicity during and after treatment; according to:
* The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
* Novel Chest Toxicity Scale for Women with Breast Cancer
* Chest photograph
Timepoint [1] 369811 0
*Pre radiotherapy
* A minimum of weekly during PMRT
* Post PMRT (week 1 and week 2)
* Weekly until side effects resolved where applicable
* Week 6 post-PMRT
Secondary outcome [2] 369812 0
Rates of other acute PMRT toxicity

A trial-specific paper flow-sheet will be completed by clinicians documenting skin toxicity during and after treatment; according to:
* The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Timepoint [2] 369812 0
*Pre radiotherapy
* A minimum of weekly during PMRT
* post PMRT (week 1 and week 2)
* where applicable weekly until side effects resolved
* week 6 post-PMRT.

Eligibility
Key inclusion criteria
* Women aged greater than or equal to 18 years old
* Breast cancer diagnosis
* Patient has undergone mastectomy
* Require RT to either chest wall or neo-breast; (temporary expander or implant in situ following mastectomy).
* Bolus must be used with RT
* Available for follow-up on a weekly basis (minimum) during RT, for two weeks after RT, then until resolution of moist desquamation; and at 6 weeks after RT
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous RT to the ipsilateral chest wall
* Autologous breast reconstruction
* Not suitable for RT to either chest wall or neo-breast as per the treating clinician

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation code will be generated from a computer using a dynamic (real-time) computer-based allocation system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a two-arm multicentre randomised evaluation study.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
The two standard methods of skin care that will be compared are Mepitel film and StrataXRT. The main purpose of the trial is to determine if one of the two methods has the least overall financial cost (materials and nursing management time) and provides the least acute toxicity, to optimise a woman’s treatment experience and to minimise costs on the healthcare system.
For the primary aim, with two groups of 30 patients in each group (60 patients in total), there is a 90% power of detecting a statistically significant difference between an average cost of $312.50 for patients treated with Mepitel versus $250 for patients treated with StrataXRT, provided the standard deviation of the cost within each group is less than or equal to $73 AUD.

The study will cease enrolling patients when 60 randomised patients have completed the six-week follow-up. Following the end of accrual, the analysis will be performed.
Analysis of this study will be unadjusted for prognostic factors and will be performed by the intention-to-treat principle for primary analysis. Statistical tests to be used include the paired and independent T-tests, Chi-squared and correlation tests, and regression analysis. Data interrogation will use 95% confidence intervals, 2-sided p-values where alpha=0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/11/2019
Actual
31/08/2020
Date of last participant enrolment
Anticipated
19/11/2023
Actual
Date of last data collection
Anticipated
19/11/2023
Actual
Sample size
Target
60
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13671 0
Westmead Hospital - Westmead
Recruitment hospital [2] 25869 0
St George Hospital - Kogarah
Recruitment hospital [3] 25870 0
GenesisCare - Hurstville - Hurstville
Recruitment postcode(s) [1] 26353 0
2145 - Westmead
Recruitment postcode(s) [2] 41702 0
2217 - Kogarah
Recruitment postcode(s) [3] 41703 0
2220 - Hurstville

Funding & Sponsors
Funding source category [1] 302623 0
Hospital
Name [1] 302623 0
Westmead Hospital
Country [1] 302623 0
Australia
Primary sponsor type
Hospital
Name
Western Sydney Local Health District
Address
Westmead Hospital
Cnr Hawkesbury Road and Darcy Road
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 302533 0
None
Name [1] 302533 0
Address [1] 302533 0
Country [1] 302533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303253 0
Western Sydney Local Health District HREC
Ethics committee address [1] 303253 0
Ethics committee country [1] 303253 0
Australia
Date submitted for ethics approval [1] 303253 0
17/07/2019
Approval date [1] 303253 0
10/10/2019
Ethics approval number [1] 303253 0
2019/ETH011506

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93022 0
A/Prof Kirsty STUART
Address 93022 0
Westmead Breast Cancer Institute
Sydney West Radiation Oncology Network
The Crown Princess Mary Cancer Centre Westmead
Westmead Hospital
PO Box 143
Westmead NSW 2145
Country 93022 0
Australia
Phone 93022 0
+61 2 8890 5200
Fax 93022 0
Email 93022 0
kirsty.stuart@health.nsw.gov.au
Contact person for public queries
Name 93023 0
Tracy PEARL-LARSSON
Address 93023 0
Sydney West Radiation Oncology Network
The Crown Princess Mary Cancer Centre Westmead
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Country 93023 0
Australia
Phone 93023 0
+61 2 8890 5200
Fax 93023 0
Email 93023 0
WSLHD-SWRON-CRU@health.nsw.gov.au
Contact person for scientific queries
Name 93024 0
Kirsty STUART
Address 93024 0
Westmead Breast Cancer Institute
Sydney West Radiation Oncology Network
The Crown Princess Mary Cancer Centre Westmead
Westmead Hospital
PO Box 143
Westmead NSW 2145
Country 93024 0
Australia
Phone 93024 0
+61 2 8890 5200
Fax 93024 0
Email 93024 0
kirsty.stuart@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant privacy. Data will be statistically summarised.


What supporting documents are/will be available?

No Supporting Document Provided



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.