Non-invasive physical plasma for preventing radiation dermatitis in breast cancer: Results from an intrapatient-randomised double-blind placebo-controlled trial.

Autor:	Dejonckheere CS; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Layer JP; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany.; Institute of Experimental Oncology, University Hospital Bonn, 53127 Bonn, Germany., Nour Y; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Layer K; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Glasmacher A; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Wiegreffe S; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Fuhrmann A; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Caglayan L; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Grau F; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Sarria GR; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Scafa D; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Koch D; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Heimann M; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Leitzen C; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Köksal MA; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Röhner F; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Müdder T; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany., Dejonckheere E; Faculty of Psychology and Educational Sciences, KU Leuven, 3000 Leuven, Belgium.; Department of Medical and Clinical Psychology, Tilburg School of Social and Behavioural Sciences, 5037 Tilburg, the Netherlands., Schmeel FC; Department of Neuroradiology, University Hospital Bonn, 53127 Bonn, Germany., Anzböck T; Department of Gynaecology, Division of Gynaecological Oncology, University Hospital Bonn, 53127 Bonn, Germany., Lindner K; Department of Gynaecology, Division of Senology, University Hospital Bonn, 53127 Bonn, Germany., Bachmann A; Department of Gynaecology, Division of Senology, University Hospital Bonn, 53127 Bonn, Germany., Abramian A; Department of Gynaecology, Division of Senology, University Hospital Bonn, 53127 Bonn, Germany., Kaiser C; Department of Gynaecology, Division of Senology, University Hospital Bonn, 53127 Bonn, Germany., Faridi A; Department of Gynaecology, Division of Senology, University Hospital Bonn, 53127 Bonn, Germany., Mustea A; Department of Gynaecology, Division of Gynaecological Oncology, University Hospital Bonn, 53127 Bonn, Germany., Giordano FA; Department of Radiation Oncology, University Medical Center Mannheim, 68167 Mannheim, Germany., Stope MB; Department of Gynaecology, Division of Gynaecological Oncology, University Hospital Bonn, 53127 Bonn, Germany., Schmeel LC; Department of Radiation Oncology, University Hospital Bonn, 53127 Bonn, Germany.
Jazyk:	angličtina
Zdroj:	Clinical and translational radiation oncology [Clin Transl Radiat Oncol] 2023 Nov 04; Vol. 44, pp. 100699. Date of Electronic Publication: 2023 Nov 04 (Print Publication: 2024).
DOI:	10.1016/j.ctro.2023.100699
Abstrakt:	Background and Purpose: To investigate the effect of topical non-invasive physical plasma (NIPP), a volatile mix generated out of ambient air, on prevention of acute radiation dermatitis (RD) during and after whole-breast irradiation (WBI). Materials and Methods: Lateral and medial breast halves were randomised within each patient to receive either 120 s of NIPP or sham treatment daily during WBI. Standard skin care with urea lotion was applied to the whole breast. Blinded acute skin toxicity was assessed weekly for each breast half separately and included clinician- (CTCAE) and patient-reported (modified RISRAS), and objective (spectrophotometry) assessments. As an additional external control, a comparable standard of care (SoC) patient collective from a previous prospective trial was used. Results: Sixty-four patients were included. There were no significant differences between breast halves. Post-hoc comparison with a similar SoC control collective revealed OR = 0.28 (95% CI 0.11-0.76; p  = 0.014) for grade ≥ 2 RD upon WBI completion, along with less hyperpigmentation ( p  < 0.001), oedema ( p  = 0.020), dry ( p  < 0.001) and moist desquamation ( p  = 0.017), pain, itching, and burning ( p  < 0.001 for each). Tolerability of NIPP was excellent and side effects were not observed. Conclusion: Even though there were no differences between intrapatient-randomised breast halves, the overall incidence and severity of acute radiation-induced skin toxicity were considerably lower when compared to a prospectively collected SoC cohort. Our data suggest the potential benefit of NIPP in RD prevention. A randomised trial with a physical control group is warranted to confirm these promising results (DRKS00026225). Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2023 The Authors. Published by Elsevier B.V. on behalf of European Society for Radiotherapy and Oncology.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu