Retrospective Cohort Study Comparing a Novel Gel Dressing vs SoC in the Treatment of Radiation Dermatitis

Stratpharma

Status: Completed

Conditions: Radiation Dermatitis

Treatments: Drug: Aquaphor; Device: StrataXRT; Drug: Calendula

Study type: Observational

Funder types: Industry

Identifiers

NCT05810194

SPASX020

Details and patient eligibility

About

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.

Enrollment: 344 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

344 participants in 2 patient groups

StrataXRT

Treatment:

Device: StrataXRT

Standard of care

Treatment:

Drug: Aquaphor

Drug: Calendula