Back to resultsStrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
StrataXRT
Sorbolene
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Dermatitis
Eligibility Criteria
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
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
Sites / Locations
- Townsville Cancer Center, Townsville Hospital and Health Service
- Princess Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
StrataXRT
Standard of care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Radiation dermatitis reaction as assessed by blinded assessment of digital photographs using the CTCAE v4.0 radiation dermatitis grades. CTCAE v4.0 severity grades are categorical with 5 possible categories (1, 2, 3, 4, 5). Grade 1 represents the weakest form of radiation dermatitis. Higher CTCAE Grades represent increasing radiation dermatitis severity.
Radiation induced skin reaction assessment scale (RISRAS)
Radiation dermatitis reaction as assessed by the clinician during patient consultations using the eviQ RISRAS form. RISRAS scale is continuous scale from 0 to 36, with higher RISRAS scores representing higher severity of radiation dermatitis.
Secondary Outcome Measures
Onset of radiation dermatitis
Timepoint of onset of CTCAE v4.0 radiation dermatitis Grades 2 and/or 3 during or after radiotherapy.
Length of time until resolution of radiation dermatitis
Length of time from peak incidence to resolution of radiation dermatitis.
Patient reported symptoms treatment
Patient reported comfort scale obtained using the eviQ RISRAS form.
Cost-effectiveness
The mean total cost of skin care per patient.
Incidence of late-effects skin toxicity
The late skin toxicity post-radiotherapy assessed using the Radiation Therapy Oncology Group (RTOG) grading definitions:
Grade 0: No change over baseline Grade I: Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating Grade II: Tender or bright erythema, patchy moist desquamation, moderate oedema Grade III: Confluent, moist desquamation other than skin folds, pitting oedema Grade IV: Ulceration haemorrhage, necrosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05450848
Brief Title
StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Official Title
A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratpharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Site investigators will load the digital photographs taken at each weekly assessment into each participant's MOSAIQ record. They will then send de-identified copies to the Central Trial Coordinator who will distribute them to the study investigators who will be performing the blinded assessment. Each weekly photograph will be independently assessed by two study investigators using the CTCAE 4.0 scale for radiation dermatitis (Appendix 1). The study investigators will complete the supplied photograph assessment form and return them to the Central Trial Coordinator.
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
StrataXRT
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
StrataXRT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sorbolene
Intervention Description
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.
Primary Outcome Measure Information:
Title
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Description
Radiation dermatitis reaction as assessed by blinded assessment of digital photographs using the CTCAE v4.0 radiation dermatitis grades. CTCAE v4.0 severity grades are categorical with 5 possible categories (1, 2, 3, 4, 5). Grade 1 represents the weakest form of radiation dermatitis. Higher CTCAE Grades represent increasing radiation dermatitis severity.
Time Frame
From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Title
Radiation induced skin reaction assessment scale (RISRAS)
Description
Radiation dermatitis reaction as assessed by the clinician during patient consultations using the eviQ RISRAS form. RISRAS scale is continuous scale from 0 to 36, with higher RISRAS scores representing higher severity of radiation dermatitis.
Time Frame
From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Secondary Outcome Measure Information:
Title
Onset of radiation dermatitis
Description
Timepoint of onset of CTCAE v4.0 radiation dermatitis Grades 2 and/or 3 during or after radiotherapy.
Time Frame
From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Title
Length of time until resolution of radiation dermatitis
Description
Length of time from peak incidence to resolution of radiation dermatitis.
Time Frame
From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Title
Patient reported symptoms treatment
Description
Patient reported comfort scale obtained using the eviQ RISRAS form.
Time Frame
From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months
Title
Cost-effectiveness
Description
The mean total cost of skin care per patient.
Time Frame
From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Title
Incidence of late-effects skin toxicity
Description
The late skin toxicity post-radiotherapy assessed using the Radiation Therapy Oncology Group (RTOG) grading definitions:
Grade 0: No change over baseline Grade I: Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating Grade II: Tender or bright erythema, patchy moist desquamation, moderate oedema Grade III: Confluent, moist desquamation other than skin folds, pitting oedema Grade IV: Ulceration haemorrhage, necrosis
Time Frame
3 - 12 months post radiation treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Facility Information:
Facility Name
Townsville Cancer Center, Townsville Hospital and Health Service
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Princess Alexandra Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
12. IPD Sharing Statement
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StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
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