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

Abstract

Aim: Investigate the effects of StrataXRT Ò 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 Ò 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 Ò patients experiencing lower mean skin toxicity at the end of the radiation treatment (P = 0.002). At the end of treatment, the StrataXRT Ò 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 Ò 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 Ò 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 Ò is effective for preventing, and delaying the development of grade 2 and 3 skin toxicity. Trial registration: ACTRN12616000511437.

Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment

“…However, a subsequent study found neither a statistical difference for skin reactions nor for moist desquamation rates between treatment and control arms [15,16]. However, another randomized study with head and neck squamous cell cancer (HNSCC) patients investigated a quite similar, film-forming silicone fluid and reported significantly reduced dermatitis rates [33].…”

Mepitel Film is superior to Biafine cream in managing acute radiation‐induced skin reactions in head and neck cancer patients: a randomised intra‐patient controlled clinical trial

“…An Australian trial compared a silicone-film producing gel, StrataXRT, with sorbolene cream for skin reaction severity in 197 head and neck cancer patients in a twoarmed design. 32 The authors showed that patients treated with StrataXRT had a 12% lower risk of developing grade 2 and a 36% lower risk of developing of grade 3 using the CTCAE v4 scale. StrataXRT was applied by the patients twice a day.…”

Selection of Appropriate Wound Dressing for Various Wounds

“…The results showed that although 3M TM film dressings and corticosteroids were not significantly different vs. control in all respects, 3M TM film dressings may reduce skin itching, while corticosteroids may delay the onset of severe skin inflammation (Shaw et al, 2015). In a singleblind, randomized controlled trial for the prophylactic use of a silicone-based film forming gel dressing (StrataXRT R Stratpharma AG, Basel, Switzerland) in patients with head and neck cancer undergoing radiation therapy, the results show that it is effective for preventing, and delaying the development of grade 2 and 3 skin toxicity (Chan et al, 2019).…”