Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis
- Registration Number
- NCT05810194
- Lead Sponsor
- Stratpharma AG
- Brief Summary
Routinely collected data on radiation-induced skin toxicity from 2010 to 2022 will be retrospectively analyzed. Data will be split into two cohorts: patients that received 1) StrataXRT and 2) standard of care. The incidence of grade ≥ 2 radiation dermatitis, the time to onset of grade ≥ 2 radiation dermatitis, the radiation dose at onset of grade ≥ 2 radiation dermatitis, the incidence of moist desquamation and the number of treatment interruptions will be compared between the cohorts.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 344
- Diagnosed with Head and Neck cancer treated with radiation therapy with or without chemotherapy
- Fractionated courses including at least 30 fractions (treatments)
- Minimum of 18 completed radiation treatments
- Radiation dose: > 50 Gy
- Radiation technique: IMRT
- Radiation equipment: TrueBeam or Tomotherapy
- Prior radiation to the treatment area
- Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
- Patients undergoing SBRT
- Patients with existing rashes or wounds in the target region or radiation therapy at RT start
- Patients receiving hypofractionation
- Patient receiving bolus
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description StrataXRT StrataXRT - Standard of care Aquaphor - Standard of care Calendula -
- Primary Outcome Measures
Name Time Method CTCAE for Radiation Dermatitis 5 weeks Acute radiation dermatitis measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score (grade 0 - 5). A higher grade is considered a worse outcome.
- Secondary Outcome Measures
Name Time Method Number of patients requiring Mepilex application 5 weeks Total number of patients that required Mepilex application during radiotherapy
Number of patients requiring burn cream application 5 weeks Total number of patients that required burn cream application during radiotherapy
Interval between radiotherapy start and burn cream application 5 weeks Number of days between initiation of radiation therapy and first application of burn cream during radiotherapy
CTCAE for Hyperpigmentation 5 weeks Acute hyperpigmentation measured weekly during radiotherapy treatment, using the Common Terminology Criteria for Adverse Events (CTCAE) score (grade 0 - 2). A higher grade is considered a worse outcome.
Interval between radiotherapy start and Mepilex application 5 weeks Number of days between initiation of radiation therapy and first application of Mepilex during radiotherapy
Trial Locations
- Locations (1)
University of California
🇺🇸Los Angeles, California, United States