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Trial registered on ANZCTR


Registration number
ACTRN12616000774426
Ethics application status
Approved
Date submitted
31/05/2016
Date registered
14/06/2016
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Study: Efficacy of StrataXRT use at Townsville Cancer Center for Radiation Dermatitis in Breast Cancer Patients
Scientific title
A Pilot Study: Efficacy of StrataXRT use at Townsville Cancer Center for Radiation Dermatitis in Breast Cancer Patients
Secondary ID [1] 289337 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation Induced skin reactions 298918 0
breast cancer 298951 0
erythema 298953 0
moist or dry desquamation 298955 0
Condition category
Condition code
Cancer 298996 298996 0 0
Breast
Skin 299043 299043 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to examine the use of StrataXRT silicone gel in the management and prophylaxis of skin reactions on patients receiving external beam radiation therapy to the whole breast at Townsville Cancer Center (TCC). StrataXRT is Therapeutic Goods Administration approved product in Australia. The silcone-based gel has two aims: prophylatic care of skin to reduce skin reactions and improve skin care management once a reaction occurs. The outcomes from this pilot will also help investigators determine if further study is warranted.

A 20 gram tube of StrataXRT will be provided to the patient. Stratpharma, the pharmaceutical company representing StrataXRT, have indicated that one tube should be sufficient for the entire length of treatment, with one application per day for five weeks of treatment with enough product left over for post-treatment application. Additional StrataXRT gel will be provided if required.

The first application of StrataXRT will be on the patient’s first day of treatment and will be done by the investigating radiation therapists as recommended by Stratpharma. This will continue for the first week of treatment and ensures the correct amount (approximately the size of a 5 cent coin) is applied.
The gel should form a thin, clear barrier if applied properly.

During this time, patients will be instructed on the correct application of the product by one of the two investigating therapists. This will facilitate correct application by the individual patient for the remainder of treatment. Patients should continue to use their allocated product until the skin reaction has resolved.

In patients where moist desquamation develops, StrataXRT will continue to be used for skin care. Patients using Sorbolene cream will see nursing staff for appropriate management or dressings

Adherence to the product will be queried at weekly review. As with current standard skin care, self-reporting adherence is the only monitor of compliance.
If patients are unable to comply with skin care product application, they will taken off the trial.
Intervention code [1] 294874 0
Treatment: Other
Intervention code [2] 294926 0
Prevention
Comparator / control treatment
The patients randomised to the control arm of this trial will receive the current stanadard skin care management at TCC. That is, and aqueous cream, Sorbolene, throughout their radiation therapy treatment,
Sorbolene is applied daily after treatment and increased with frequency as required.
Control group
Active

Outcomes
Primary outcome [1] 298463 0
Skin reaction grading is the primary outcome which will be measured with a skin grading assessment sheet and clinical photographs. The assessment sheet is designed by Stratpharma and is based on the Radiation Induced Skin Reaction Assessment Scale (RISRAS) created by Noble-Adams.
Timepoint [1] 298463 0
The primary outcome will be assessed for each patient on a weekly basis. Day one will provide a baseline measurement, and skin reaction will be graded weekly thereafter until the completion of treatment.
The control group receiving standard care will be compared against StrataXRT group for skin reaction grading once all patients on the study have completed treatment.
Secondary outcome [1] 324220 0
Satisfaction with the product- ease of use. This will be measured using an assessment sheet.
The assessment sheet has been provided by Stratpharma and will be used for a larger, multi-center study that will assess StrataXRT, as well as this smaller pilot study.
Timepoint [1] 324220 0
As with primary endpoint, baseline assessment of product will occur at Day 1 and weekly thereafter until the completion of treatment.

Eligibility
Key inclusion criteria
Inclusion Criteria:
* Patients need to be receiving/ or scheduled to receive external beam radiation therapy in order to be eligible.
* Early or Local staged breast cancer
* Aged 18 years or older
* Histological or cytologically confirmed Breast cancer
* Patients with a whole intact breast
* An ECOG performance status score of 1 or less
* Has provided written Informed Consent for participation in this trial
* Treatment in the supine position
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
* Evidence of distant metastases
* Already exposed to ionising radiation in the affected area
* Any patients requiring bolus
* Dose constraints to critical structures are not achieved
* Pregnant women and human foetus
* Under 18 years of age
* Unable to consent
* Any cognitive or mental impairment that could prevent compliance to the required protocol
* Any patients who deviate from standard protocol

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)
Randomisation will occur utilising the “envelope method” whereby five envelopes contain Arm 1 and five envelopes contain Arm 2. Envelopes are constructed by a separate, uninvolved third party and shuffled by this third party to reduce bias due to sequential order. The patient will be given an envelope containing the arm they will belong to for the duration of treatment. As StrataXRT will be applied by the investigators for the first week of treatment, investigators will be required to know which arm the patient belongs to following randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur utilising the “envelope method” whereby five envelopes contain Arm 1 and five envelopes contain Arm 2. Envelopes are constructed by a separate, uninvolved third party and shuffled by this third party to reduce bias due to sequential order. The patient will be given an envelope containing the arm they will belong to for the duration of treatment. As StrataXRT will be applied by the investigators for the first week of treatment, investigators will be required to know which arm the patient belongs to following randomisation.
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
For the pilot study, initial data analysis will be based on the RTOG scale for radiation dermatitis. Clinical photographs will be review for assessment of skin reactions throughout treatment. The 10 patients accrued will be assessed by a team comprised of radiation therapists, Radiation Oncologists and radiation oncology nurses to determine if a phase two study is indicated. All analyses will be performed by the investigators and will not involve Stratpharma, the pharmaceutical company who provide the product

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] 5859 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 13300 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 293694 0
Commercial sector/Industry
Name [1] 293694 0
Stratpharma
Address [1] 293694 0
Centralbahnpl. 8, 4051 Basel, Switzerland
Country [1] 293694 0
Switzerland
Funding source category [2] 293802 0
Hospital
Name [2] 293802 0
The Townville Hospital
Address [2] 293802 0
100 Angus Smith Drive
Douglas 4814
Queensland
Australia
Country [2] 293802 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
100 Angus-Smith Drive
Douglas 4814
Queensland
Australia
Country
Australia
Secondary sponsor category [1] 292528 0
None
Name [1] 292528 0
None
Address [1] 292528 0
N/A
Country [1] 292528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295134 0
Human Research Ethics Committee, Townsville Hospital and Health Service
Ethics committee address [1] 295134 0
100 Angus-Smith Drive
Douglas 4814
Queensland
Ethics committee country [1] 295134 0
Australia
Date submitted for ethics approval [1] 295134 0
22/04/2016
Approval date [1] 295134 0
06/06/2016
Ethics approval number [1] 295134 0
HREC/16/QTHS/90

Summary
Brief summary
TThis study is being conducted to assess a new skin product against the standard skin care procedures at Townsville Cancer Center (TCC) in breast cancer patients receiving external beam radiation therapy.
Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have a confirmed diagnosis of breast cancer, for which you will be undergoing external beam radiation therapy.
Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive the current standard skin care management. That is, an aqueous cream, Sorbolene, applied daily after radiation therapy treatment. Participants in the other group will instead receive a new product called StrataXRT, which is a silicone based gel applied to the skin which acts as a barrier to prevent the development of radiation-induced skin reactions. The product is TGA approved in Australia; FDA approved in the United States and is being used clinically in other centres in Australia. All participants will be assessed at the beginning of treatment and weekly thereafter using a specific skin grading scale, and clinical photographs will be taken.
The study is attempting to determine if StrataXRT is equivalent to current practices, and whether further study on the product is warranted.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66054 0
Miss KYLIE ROBBIE
Address 66054 0
The Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814

Country 66054 0
Australia
Phone 66054 0
+61 7 44 33 1664
Fax 66054 0
+61 7 44 33 1664
Email 66054 0
Kylie.Robbie@health.qld.gov.au
Contact person for public queries
Name 66055 0
Miss Amber Scull
Address 66055 0
The Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814
Country 66055 0
Australia
Phone 66055 0
+61 7 44 33 1664
Fax 66055 0
+61 7 44 33 1661
Email 66055 0
Amber.Scull@health.qld.gov.au
Contact person for scientific queries
Name 66056 0
Dr Susan Hewitt
Address 66056 0
The Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814
Country 66056 0
Australia
Phone 66056 0
+61 7 44 33 1663
Fax 66056 0
+61 7 44 33 1661
Email 66056 0
Susan.hewitt@health.qld.gov.au

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