A Randomised Comparison of StrataXRT to Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stratpharma AG
- Enrollment
- 105
- Locations
- 4
- Primary Endpoint
- Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame: 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)
Time Frame: 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 Outcomes
- Length of time until resolution of radiation dermatitis(From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months)
- Cost-effectiveness(From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months)
- Onset of radiation dermatitis(From radiotherapy start, until to 4 weeks post radiation therapy; up to 3 months)
- Patient reported symptoms treatment(From onset of radiation dermatitis, until radiation dermatitis resolution, up to 3 months)
- Incidence of late-effects skin toxicity(3 - 12 months post radiation treatment)