Raymond J Chan1, Rae Blades2, Lee Jones3, Tai-Rae Downer4, Samuel C Peet5, Elise Button2, David Wyld2, Steven McPhail6, Melissa Doolan5, Patsy Yates7. 1. Princess Alexandra Hospital, Metro South Health and Hospital Services, Woolloongabba, Q4102, Queensland, Australia; School of Nursing, Queensland University of Technology, Kelvin Grove, Q4059, Queensland, Australia. Electronic address: Raymond.chan@qut.edu.au. 2. School of Nursing, Queensland University of Technology, Kelvin Grove, Q4059, Queensland, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Q4029, Queensland, Australia. 3. Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove, Q4029, Queensland, Australia. 4. School of Nursing, Queensland University of Technology, Kelvin Grove, Q4059, Queensland, Australia. 5. Cancer Care Services, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Q4029, Queensland, Australia. 6. Australian Centre for Health Services Innovation and School of Public Health & Social Work, Queensland University of Technology, Kelvin Grove, Q4029, Queensland, Australia. 7. Princess Alexandra Hospital, Metro South Health and Hospital Services, Woolloongabba, Q4102, Queensland, Australia; School of Nursing, Queensland University of Technology, Kelvin Grove, Q4059, Queensland, Australia; Cancer Care Services, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, Q4029, Queensland, Australia.
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 receivingradical 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. Crown
RCT Entities:
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. Crown
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