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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05450848




Registration number
NCT05450848
Ethics application status
Date submitted
22/06/2022
Date registered
11/07/2022
Date last updated
12/07/2023

Titles & IDs
Public title
StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Scientific title
A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Secondary ID [1] 0 0
SPASX01AU002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Radiation Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - StrataXRT
Other interventions - Sorbolene

Experimental: StrataXRT - Patients allocated to receive StrataXRT will be provided with StrataXRT gel to apply twice daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided.

Active comparator: Standard of care - Patients allocated to receive standard care will be provided with aqueous cream to apply daily to the irradiated area until any radiation dermatitis that may occur has resolved. In case the patient develops radiation dermatitis that results in moist desquamation, IntraSiteTM gel (Smith and Nephew, UK) and secondary dressings will be provided.


Treatment: Devices: StrataXRT
StrataXRT is a flexible wound dressing for the prevention and treatment of radiation dermatitis. It is in the form of a gel which, when applied, creates a protective film that maintains skin integrity. The product is used to relieve low grade inflammatory radiation changes such as dry, itching, flaking, peeling and irritated skin. For more severe inflammatory changes with open wound components, StrataXRT reduces pain, redness and heat and helps soothe the exposed skin areas. StrataXRT can be applied where skin integrity has been compromised and may also be used in conjunction with other adjunctive treatments to improve overall results. StrataXRT contains Polydimethylsiloxanes, Siloxanes and Alkylmethyl Silicones and is transparent and odourless. It does not contain alcohols, parabens or fragrances. StrataXRT can be used with or without a secondary protective dressing. It is suitable for children and people with sensitive skin.

Other interventions: Sorbolene
Aqueous cream (moisturizer) that soothes itchiness and dryness of the skin, and aids skin hydration. It is non-greasy, fragrance free, colour free, GMO free, paraben free and pH balanced.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Timepoint [1] 0 0
From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Primary outcome [2] 0 0
Radiation induced skin reaction assessment scale (RISRAS)
Timepoint [2] 0 0
From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Secondary outcome [1] 0 0
Onset of radiation dermatitis
Timepoint [1] 0 0
From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Secondary outcome [2] 0 0
Length of time until resolution of radiation dermatitis
Timepoint [2] 0 0
From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Secondary outcome [3] 0 0
Patient reported symptoms treatment
Timepoint [3] 0 0
From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Secondary outcome [4] 0 0
Cost-effectiveness
Timepoint [4] 0 0
From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Secondary outcome [5] 0 0
Incidence of late-effects skin toxicity
Timepoint [5] 0 0
3 - 12 months post radiation treatment

Eligibility
Key inclusion criteria
* Patients with cancer undergoing a curative course of radiation therapy using standard protocols to the following cancer sites:

* Head and neck cancers receiving >= 60Gy who are not receiving concurrent Cetuximab
* Intact breast receiving >= 40Gy (includes patients receiving boost fields using photon or elections)
* Post-mastectomy chest wall (breast cancer diagnosis only) receiving >= 50Gy
* Gynaecological cancers requiring whole pelvis irradiation receiving >= 45Gy
* Skin cancers to the axilla/groin regions receiving >= 40Gy
* Male and female patients >18 years of age
* Patients who do not have a known allergy to silicon
* Patients who are able to attend the four post-treatment weekly skin assessment appointments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ineligible participants are patients undergoing a course of curative radiation therapy:

* Who are participating in another interventional study
* With an allergy to product content (standard or StrataXRT)
* With an existing skin rash, ulceration or open wound in the treatment area
* With a pre-existing systemic skin disease (dermatological conditions, connective tissue disorders)
* Who have had previous radiation therapy to the current treatment area
* Who are on immuno-suppression drugs

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Townsville Cancer Center, Townsville Hospital and Health Service - Douglas
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
4814 - Douglas
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Stratpharma AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.
Trial website
https://clinicaltrials.gov/study/NCT05450848
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05450848