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dc.contributor.authorChan, RJ
dc.contributor.authorBlades, R
dc.contributor.authorJones, L
dc.contributor.authorDowner, TR
dc.contributor.authorPeet, SC
dc.contributor.authorButton, E
dc.contributor.authorWyld, D
dc.contributor.authorMcPhail, S
dc.contributor.authorDoolan, M
dc.contributor.authorYates, P
dc.date.accessioned2019-09-09T23:59:25Z
dc.date.available2019-09-09T23:59:25Z
dc.date.issued2019
dc.identifier.issn0167-8140en_US
dc.identifier.doi10.1016/j.radonc.2019.07.014en_US
dc.identifier.urihttp://hdl.handle.net/10072/387133
dc.description.abstractAim: 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.en_US
dc.description.peerreviewedYesen_US
dc.languageEnglishen_US
dc.publisherElsevieren_US
dc.publisher.placeNetherlands
dc.relation.ispartofpagefrom1en_US
dc.relation.ispartofpageto7en_US
dc.relation.ispartofjournalRadiotherapy and Oncologyen_US
dc.subject.fieldofresearchOncology and Carcinogenesisen_US
dc.subject.fieldofresearchOther Physical Sciencesen_US
dc.subject.fieldofresearchcode1112en_US
dc.subject.fieldofresearchcode0299en_US
dc.titleA 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 canceren_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Articlesen_US
dcterms.bibliographicCitationChan, RJ; Blades, R; Jones, L; Downer, TR; Peet, SC; Button, E; Wyld, D; McPhail, S; Doolan, M; Yates, P, 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, Radiotherapy and Oncology, 2019, pp. 1-7en_US
dcterms.licensehttp://creativecommons.org/licenses/by-nc-nd/4.0/en_US
dc.date.updated2019-09-09T23:50:46Z
dc.description.versionPublisheden_US
gro.description.notepublicThis publication has been entered into Griffith Research Online as an Advanced Online Version.en_US
gro.rights.copyright© 2019 Published by Elsevier B.V. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International (CC BY-NC-ND 4.0) License, which permits unrestricted, non-commercial use, distribution and reproduction in any medium, providing that the work is properly cited.en_US
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gro.griffith.authorChan, Ray


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