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Non-invasive physical plasma for preventing radiation dermatitis in breast cancer: results from an intrapatient-randomised double-blind placebo-controlled trial: original research article

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...

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Main Authors: Dejonckheere, Cas S. (Author) , Layer, Julian Philipp (Author) , Nour, Younèss (Author) , Layer, Katharina (Author) , Glasmacher, Andrea (Author) , Wiegreffe, Shari (Author) , Fuhrmann, Arne (Author) , Caglayan, Lara (Author) , Grau, Franziska (Author) , Sarria, Gustavo Renato (Author) , Scafa, Davide (Author) , Koch, David (Author) , Heimann, Martina (Author) , Leitzen, Christina (Author) , Köksal, Mümtaz Ali (Author) , Röhner, Fred (Author) , Müdder, Thomas (Author) , Dejonckheere, Egon (Author) , Schmeel, Frederic Carsten (Author) , Anzböck, Teresa (Author) , Lindner, Kira (Author) , Bachmann, Anne (Author) , Abramian, Alina (Author) , Kaiser, Christina (Author) , Faridi, Andree (Author) , Mustea, Alexander (Author) , Giordano, Frank Anton (Author) , Stope, Matthias Bernhard (Author) , Schmeel, Leonard Christopher (Author)
Format: Article (Journal)
Language:English
Published: January 2024
In: Clinical and translational radiation oncology
Year: 2024, Volume: 44, Pages: 1-11
ISSN:2405-6308
DOI:10.1016/j.ctro.2023.100699
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ctro.2023.100699
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S2405630823001246
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Author Notes:Cas Stefaan Dejonckheere, Julian Philipp Layer, Younèss Nour, Katharina Layer, Andrea Glasmacher, Shari Wiegreffe, Arne Fuhrmann, Lara Caglayan, Franziska Grau, Gustavo Renato Sarria, Davide Scafa, David Koch, Martina Heimann, Christina Leitzen, Mümtaz Ali Köksal, Fred Röhner, Thomas Müdder, Egon Dejonckheere, Frederic Carsten Schmeel, Teresa Anzböck, Kira Lindner, Anne Bachmann, Alina Abramian, Christina Kaiser, Andree Faridi, Alexander Mustea, Frank Anton Giordano, Matthias Bernhard Stope, Leonard Christopher Schmeel
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Summary: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).
Item Description:Online verfügbar: 4. November 2023, Artikelversion: 4. November 2023
Gesehen am 18.07.2024
Physical Description:Online Resource
ISSN:2405-6308
DOI:10.1016/j.ctro.2023.100699

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