A single-blind, randomised controlled trial of StrataXRT® – A silicone-based film-forming gel dressing for prophylaxis and management of radiation dermatitis in patients with head and neck cancer

Raymond J. Chan, Rae Blades, Lee Jones, Tai Rae Downer, Samuel C. Peet, Elise Button, David Wyld, Steven McPhail, Melissa Doolan, Patsy Yates

Research output: Contribution to journalArticlepeer-review

12 Citations (Scopus)

Abstract

Aim: Investigate the effects of StrataXRT® versus 10% Glycerine (Sorbolene cream) for preventing and managing radiation dermatitis in patients with head and neck cancer receiving radical radiotherapy (≥50 Gy) with or without chemotherapy or biotherapy. Methods: A single-blind, randomised controlled, superiority trial was conducted. Patients either received StrataXRT® or Sorbolene (usual care). Skin toxicity, pain, itching and skin-related quality of life scores were collected from baseline, and up to four weeks post-treatment. Results: A total of 197 patients were randomised into the study. Skin toxicity was dependent on the treatment group with StrataXRT® patients experiencing lower mean skin toxicity at the end of the radiation treatment (P = 0.002). At the end of treatment, the StrataXRT® arm had a lower percentage of grade 2 (80%) and grade 3 (28%) skin toxicity compared to the sorbolene arm (91% and 45% respectively). After adjustment for Cetuximab, the StrataXRT® arm had a 12% lower risk of experiencing grade 2 skin toxicity (RRR = 0.876, 95% CI: 0.778–0.987, P = 0.031); and a 36% lower risk of experiencing grade 3 skin toxicity (RRR = 0.648, 95% CI: 0.442–0.947, P = 0.025). Cox regression analysis showed that patients receiving StrataXRT® had a 41.0% and 49.4% reduced risks of developing grade 2 and 3 skin toxicity respectively throughout treatment compared to the Sorbolene arm. There were no differences between groups in patient-reported outcomes. No treatment interruptions and study product related adverse events were reported in either arm. Conclusion: StrataXRT® is effective for preventing, and delaying the development of grade 2 and 3 skin toxicity. Trial registration: ACTRN12616000511437.

Original languageEnglish
Pages (from-to)72-78
Number of pages7
JournalRADIOTHERAPY AND ONCOLOGY
Volume139
DOIs
Publication statusPublished - Oct 2019
Externally publishedYes

Keywords

  • Cancer
  • Radiation dermatitis
  • Radiation induced skin reaction
  • Silicone
  • Skin Toxicity
  • StrataXRT®

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