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Trial registered on ANZCTR


Registration number
ACTRN12616000511437
Ethics application status
Approved
Date submitted
16/04/2016
Date registered
20/04/2016
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Date results information initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A non-blinded, randomised, controlled, superiority trial of StrataXRT 'Registered Trademark' versus 10% Glycerine (Sorbolene) cream for prophylaxis and management of radiation dermatitis in head and neck cancer patients receiving radical radiotherapy with or without concurrent systemic therapy
Scientific title
A non-blinded, randomised, controlled, superiority trial of StrataXRT 'Registered Trademark' versus 10% Glycerine (Sorbolene) cream for prophylaxis and management of radiation dermatitis in head and neck cancer patients receiving radical radiotherapy with or without concurrent systemic therapy
Secondary ID [1] 289020 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 298436 0
Condition category
Condition code
Cancer 298533 298533 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
StrataXRT 'Registered Trademark' is a TGA-approved silicon-based topical preparation, consisting of polydimethylsiloxanes, Siloxanes, and Alkylmethyl Silicones

Patients will be asked to start topical application of their allocated topical preparation on the area of skin being irradiated at the onset of radiotherapy, twice a day until the skin reaction subsides, up to 4 weeks post treatment. The amount of topical preparation dispensed to each patient will be recorded throughout treatment. If moist desquamation occurs, Group one will continue to apply StrataXRT 'Registered Trademark' in addition to Atrauman 'Registered Trademark' dressing and non-sterile combine roll until the wound heals as per standard practice. Patients will be asked to still continue with the allocated topical preparation onto irradiated areas that have no skin breakdown. All participants will be given written instructions on how to apply the allocated treatment.
Intervention code [1] 294505 0
Prevention
Intervention code [2] 294520 0
Treatment: Devices
Comparator / control treatment
Sorbolene (usual care) is consisted of purified water, cetostearyl alcohol, liquid paraffin, white soft paraffin, caprilic/capric triglyceride, propylene glycol, cetomacrogol 1000, phenoxyethanol, methyl hydroxybenzoate and propyl hydroxybenzoate.

Patients will be asked to start topical application of their allocated topical preparation on the area of skin being irradiated at the onset of radiotherapy, twice a day or more as needed depending on the occurrence of RD and pain, up to 4 weeks post treatment. Patients will discontinue applying Sorbolene in the area of skin breakdown and Intrasite Gel, Atrauman 'Registered Trademark' and non-sterile combine roll will be applied until the wound heals as per standard practice. Patients will be asked to still continue with the allocated topical preparation onto irradiated area that has no breakdown. All participants are given written instructions on how to apply the allocated treatment.
Control group
Active

Outcomes
Primary outcome [1] 298025 0
Incidence of >Grade 2 Radiation Dermatitis (as measured by the Common Terminology Criteria for Adverse Events) (CTCAE- Version 4.0)
Timepoint [1] 298025 0
At 6 weeks of Radiation Treatment
Secondary outcome [1] 322948 0
Time to grade 1, 2, 3, and 4 of Radiation Dermatitis (as measured by the Common Terminology Criteria for Adverse Events) (CTCAE- Version 4.0)
Timepoint [1] 322948 0
This outcome is assessed once a week throughout the radiation treatment up to 4 weeks after treatment
Secondary outcome [2] 322951 0
The average levels of RD throughout the radiation treatment up to 4 weeks after treatment (as measured by the Common Terminology Criteria for Adverse Events) (CTCAE- Version 4.0)
Timepoint [2] 322951 0
This outcome is assessed once a week throughout the radiation treatment up to 4 weeks after treatment
Secondary outcome [3] 322952 0
The proportion of participants developing >Grade 2 RD (as measured by the Common Terminology Criteria for Adverse Events) (CTCAE- Version 4.0)
Timepoint [3] 322952 0
This outcome is assessed once a week throughout the radiation treatment up to 4 weeks after treatment
Secondary outcome [4] 322953 0
Levels of pain (as measured by three measures from the Brief Pain Inventory (BPI): the average, best, and worst pain, and pain relief scores from the preceding seven days)
Timepoint [4] 322953 0
This outcome is assessed once a week throughout the radiation treatment up to 4 weeks after treatment
Secondary outcome [5] 322954 0
Levels of itching (as measured by a numeric analogue scale of 0-10 in the treated skin (0= no itching at all), (10= itching as bad as you can imagine))
Timepoint [5] 322954 0
This outcome is assessed once a week throughout the radiation treatment up to 4 weeks after treatment
Secondary outcome [6] 322955 0
Level of skin related quality of life (as measured by Skindex-16)
Timepoint [6] 322955 0
Week 6 of Radiation Treatment
Secondary outcome [7] 322956 0
Healthcare resource utilisation and costs: Healthcare resources (both labour and non-labour) associated with the provision of the StrataXRT 'Registered Trademark' (intervention group), Sorbolene (usual care group) and clinical appointments, nursing labour time, or other wound management resources (e.g. wound dressings) associated with either the planned intervention (or usual care) skin management, or management of RD will be recorded for each participant throughout the trial. At the completion of the trial, unit costs will be applied at market rates to describe labour and non-labour healthcare costs associated with the planned skin intervention as well as the management of RD.
Timepoint [7] 322956 0
At the completion of the trial
Secondary outcome [8] 322958 0
Treatment interruptions
Although RD-related treatment interruptions are expected to be rare, any interruptions will be documented throughout the study (Yes/No).
Timepoint [8] 322958 0
Throughout the radiation treatment
Secondary outcome [9] 322995 0
Adverse events
There is no specific adverse event from the topical treatments. However, if any unexpected adverse events arise, we will measure this using the Common Terminology Criteria for Adverse Events) (CTCAE- Version 4.0)
Timepoint [9] 322995 0
Throughout treatment and up to 4 weeks

Eligibility
Key inclusion criteria
Participants in this study will be patients receiving radical radiotherapy +/- concurrent chemotherapy or biotherapy for head and neck cancer at the Royal Brisbane and Women's Hospital
*Age >18 years
*Patients who have a definitive diagnosis of head and neck cancer
*Patients who are receiving radiotherapy (>50 Gy) either as primary treatment or postoperative treatment to their head and neck.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Patients who are unable to consent
*Patients with pre-existing skin rash, ulceration or open wound in the treatment area
*Patients with known allergic and other systemic skin diseases even not directly affecting irradiated fields.
*Patients with any known allergic reactions towards any ingredient of either the StrataXRT 'Registered Trademark' or the Sorbolene and failed the patch test.

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)
After the research nurse has obtained the patient’s consent. The research nurse will then allocate participants to either receive StrataXRT 'Registered Trademark', or receive Sorbolene according to the generated sequence. This proposed study is a non-blinded study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked randomisation will be performed by a computer generated random number list prepared by an investigator who has no clinical involvement in the trial. Stratification by either scheduled for or on concurrent biotherapy will be carried out.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Intention to treat analyses will be carried out. Patient characteristics between arms will be compared using the chi-square test for discrete variables and the t-test for continuous variables. RDs will be evaluated using Kaplan-Meier actuarial plots (time to event) with the log-rank test for significance. Uni-variate regression models will determine the significance of factors to be included in the multivariate Cox regression model.

To address the economic-related aims of this study, skin-related healthcare resource utilisation will be summarised for both labour and non-labour items. This will include resource utilisation associated with the planned interventions for each group, as well as management of adverse skin reactions. Unit costs will be applied at market rates for the index year of the study. Cost effectiveness estimates will be generated from the perspective of a healthcare provider deciding whether or not to choose StrataXRT 'Registered Trademark' or Sorbolene (current usual care). This will be estimated using an Incremental Cost-Effectiveness Ratio’s (ICER) cost per incident of > Grade 2 RD averted derived from between group differences in costs and incidence rates of > Grade 2 RD during the trial. Due to the potential for uncertainty and non-normal distribution for some data, 95% confidence intervals (for costs and effect estimates) and a 95% confidence ellipse (for incremental cost effectiveness ratio estimates) will be derived from bootstrap resampling (2000 replications of original sample size), and cost effectiveness acceptability curves for varying threshold values of cost effectiveness will also be prepared if relevant. An assessment of the sensitivity of the results obtained to variation in measured resource use, effectiveness, time-horizon, perspective and unit costs will be undertaken where appropriate using one-way or multi-way sensitivity analyses.

Sample size
A sample size of at least 93 in each arm would be required to detect a 20% difference in the CTCAE skin toxicity scores at week 6 using a 2-sided significance level of 0.05 and a power of 80%. Assuming that approximately 5% will be lost to follow-up; an additional 5 in each group will be required so the final sample will require 196 patients (98 per arm). All eligible patients will be approached consecutively. According to the local statistics of RBWH Cancer Care Services, 270 patients receive radical radiotherapy for head and neck cancer over a twelve-month period. Thus, the sample size proposed is achievable over a period of 12 months.

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 in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5633 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 13087 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 293387 0
Commercial sector/Industry
Name [1] 293387 0
STRATPHARMA AG
Address [1] 293387 0
Centralbahnplatz 8
4051 Basel, Switzerland
Country [1] 293387 0
Switzerland
Primary sponsor type
University
Name
Queensland University of Technology
Address
Level 4, 88 Musk Ave, Kelvin Grove, QLD 4059, Australia
Country
Australia
Secondary sponsor category [1] 292207 0
Hospital
Name [1] 292207 0
Royal Brisbane and Women's Hospital
Address [1] 292207 0
Butterfield Street, Herston, QLD 4029, Australia
Country [1] 292207 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294843 0
Royal Brisbane and Women's Hospital Ethics Committee
Ethics committee address [1] 294843 0
Level 7, Block 7, Royal Brisbane and Women's Hospital, Herston, QLD 4029
Ethics committee country [1] 294843 0
Australia
Date submitted for ethics approval [1] 294843 0
30/03/2016
Approval date [1] 294843 0
26/04/2016
Ethics approval number [1] 294843 0
Ethics committee name [2] 294844 0
Queensland University of Technology
Ethics committee address [2] 294844 0
Office of Research Ethics & Integrity, Level 4, 88 Musk Avenue, Kelvin Grove, QLD 4029, Australia
Ethics committee country [2] 294844 0
Australia
Date submitted for ethics approval [2] 294844 0
02/05/2016
Approval date [2] 294844 0
27/05/2016
Ethics approval number [2] 294844 0

Summary
Brief summary
The primary purpose of this trial is to investigate the efficacy of StrataXRT in reducing the incidence and rate of onset of radiation dermatitis in head and neck cancer patients undergoing radiotherapy.
Who is it for?
You may be eligible to participate in this trial if you are aged 18 or over, and have been diagnosed with a head or neck cancer for which you are receiving radiotherapy (>50Gy) with or without concurrent chemotherapy or biotherapy.
Study details
Participants enrolled in this trial will be randomly allocated (by chance) to receive either StrataXRT gel or 10% Glycerine (Sorbolene). The allocated dressing will be applied to the irradiated skin, twice a day until the skin reaction subsides, up to 4 weeks post treatment. Participants will complete a range of questionnaires by interview every week from the start of radiotherapy and four weeks following the completion of radiotherapy, in addition to collecting data on radiation dermatitis symptoms, healthcare costs and side effects. It is hoped that results from this trial will provide information on whether StrataXRT is more safe and effective than Sorbolene for the prevention and treatment of radiation dermatitis in head and neck cancer patients undergoing radiotherapy.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 65214 0
Prof Raymond Chan
Address 65214 0
Level 2, Building 34, Royal Brisbane and Women's Hospital, Butterfield Street, QLD 4029, Australia
Country 65214 0
Australia
Phone 65214 0
+61731383842
Fax 65214 0
Email 65214 0
Raymond.Chan@qut.edu.au
Contact person for public queries
Name 65215 0
Prof Raymond Chan
Address 65215 0
Level 2, Building 34, Royal Brisbane and Women's Hospital, Butterfield Street, QLD 4029, Australia
Country 65215 0
Australia
Phone 65215 0
+61731383842
Fax 65215 0
Email 65215 0
Raymond.Chan@qut.edu.au
Contact person for scientific queries
Name 65216 0
Prof Raymond Chan
Address 65216 0
Level 2, Building 34, Royal Brisbane and Women's Hospital, Butterfield Street, QLD 4029, Australia
Country 65216 0
Australia
Phone 65216 0
+61731383842
Fax 65216 0
Email 65216 0
Raymond.Chan@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
We will decide on this with the sponsor after publication of the trial.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary