Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

Retrospective Cohort Study Comparing a Novel Silicone Gel Wound Dressing vs Standard of Care in the Treatment of Radiation Dermatitis

Keywords

Radiation Dermatitis, Dermatitis, Radiodermatitis, StrataXRT, Calendula, Aquaphor

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • University of California accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stratpharma AG
ID
NCT05810194
Study Type
Observational
Participants
Expecting 400 study participants
Last Updated