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1. A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

Author

Rossana Ingargiola, Maria Carmen De Santis, Nicola Alessandro Iacovelli, Nadia Facchinetti, Anna Cavallo, Eliana Ivaldi, Michela Dispinzieri, Marzia Franceschini, Carlotta Giandini, Domenico Attilio Romanello, Simona Di Biaso, Michela Sabetti, Laura Locati, Salvatore Alfieri, Paolo Bossi, Mauro Guglielmo, Fabio Macchi, Laura Lozza, Riccardo Valdagni, Carlo Fallai, Emanuele Pignoli, and Ester Orlandi

Subjects
Head and neck cancer, Breast cancer, Acute radiation dermatitis, Skin toxicity, Xonrid®, Skindex-16, Medical physics. Medical radiology. Nuclear medicine, R895-920, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background This study was an open-label, 2-arms, monocentric, randomized clinical trial comparing Xonrid®, a topical medical device, versus standard of care (SOC) in preventing and treating acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT). Methods Eligible HNC and BC patients were randomized 1:1 to receive Xonrid® + SOC or SOC during RT. Patients were instructed to apply Xonrid® on the irradiated area three times daily, starting on the first day of RT and until 2 weeks after RT completion or until the development of grade ≥ 3 skin toxicity. The primary endpoint was to evaluate the proportion of patients who developed an ARD grade

Published
2020
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