StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
- Conditions
- Radiation Dermatitis
- Interventions
- Device: StrataXRTOther: Sorbolene
- Registration Number
- NCT05450848
- Lead Sponsor
- Stratpharma AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
-
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
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description StrataXRT 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. Standard of care Sorbolene 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.
- Primary Outcome Measures
Name Time Method Common Terminology Criteria for Adverse Events (CTCAE) v4.0 From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months 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) From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months 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
Name Time Method Length of time until resolution of radiation dermatitis From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months Length of time from peak incidence to resolution of radiation dermatitis.
Cost-effectiveness From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months The mean total cost of skin care per patient.
Onset of radiation dermatitis From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months Timepoint of onset of CTCAE v4.0 radiation dermatitis Grades 2 and/or 3 during or after radiotherapy.
Patient reported symptoms treatment From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months Patient reported comfort scale obtained using the eviQ RISRAS form.
Incidence of late-effects skin toxicity 3 - 12 months post radiation treatment 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
Trial Locations
- Locations (2)
Townsville Cancer Center, Townsville Hospital and Health Service
🇦🇺Douglas, Queensland, Australia
Princess Alexandra Hospital
🇦🇺South Brisbane, Queensland, Australia