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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
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.
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.
Townsville Cancer Center, Townsville Hospital and Health Service
Douglas, Queensland, Australia
Princess Alexandra Hospital
South Brisbane, Queensland, Australia
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.
Time frame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
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.
Time frame: From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months
Onset of radiation dermatitis
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
Length of time until resolution of radiation dermatitis
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
Patient reported symptoms treatment
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
Cost-effectiveness
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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
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
Time frame: 3 - 12 months post radiation treatment