TY - JOUR
T1 - Non-invasive physical plasma for preventing radiation dermatitis in breast cancer
T2 - Results from an intrapatient-randomised double-blind placebo-controlled trial
AU - Dejonckheere, Cas Stefaan
AU - Layer, Julian Philipp
AU - Nour, Younèss
AU - Layer, Katharina
AU - Glasmacher, Andrea
AU - Wiegreffe, Shari
AU - Fuhrmann, Arne
AU - Caglayan, Lara
AU - Grau, Franziska
AU - Sarria, Gustavo Renato
AU - Scafa, Davide
AU - Koch, David
AU - Heimann, Martina
AU - Leitzen, Christina
AU - Köksal, Mümtaz Ali
AU - Röhner, Fred
AU - Müdder, Thomas
AU - Dejonckheere, Egon
AU - Schmeel, Frederic Carsten
AU - Anzböck, Teresa
AU - Lindner, Kira
AU - Bachmann, Anne
AU - Abramian, Alina
AU - Kaiser, Christina
AU - Faridi, Andree
AU - Mustea, Alexander
AU - Giordano, Frank Anton
AU - Stope, Matthias Bernhard
AU - Schmeel, Leonard Christopher
N1 - Publisher Copyright:
© 2023
PY - 2024/1
Y1 - 2024/1
N2 - 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).
AB - 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).
KW - Breast cancer
KW - Cold atmospheric plasma
KW - Non-invasive physical plasma
KW - Radiation dermatitis
KW - Radiation therapy
KW - Randomised controlled trial
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U2 - 10.1016/j.ctro.2023.100699
DO - 10.1016/j.ctro.2023.100699
M3 - Article
AN - SCOPUS:85176231554
SN - 2405-6308
VL - 44
JO - Clinical and Translational Radiation Oncology
JF - Clinical and Translational Radiation Oncology
M1 - 100699
ER -