Radiation Dermatitis
Conditions
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.
Interventions
DEVICEStrataXRT
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.
OTHERSorbolene
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.
Sponsors
Stratpharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
Countries
Australia
Outcome results
None listed