title: Preemptive treatment with Xonrid®, a medical device to reduce radiation induced dermatitis in head and neck cancer patients receiving curative treatment: a pilot study.
abstract: The purpose of this study was to investigate efficacy, safety and tolerability of Xonrid®, a new medical device, in preventing radiation dermatitis associated with head and neck cancer (HNC) radiotherapy (RT).
  
  
  
  In this monocentric, prospective pilot study, adult consecutive HNC patients who were planned to receive curative RT with or without chemotherapy were enrolled. Patients were instructed to apply Xonrid® on the irradiated area during treatment continuing until 2 weeks after the completion of RT or the development of severe skin toxicity. Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 scale. The patient reported outcome measures included the Skindex-16 questionnaire and patient satisfaction. Skin reflectance spectra were analyzed to objectively evaluate dermatitis.
  
  
  
  In total, 41 subjects were enrolled (30 males, median age 60 years). No skin adverse events were recorded either in the skin area where the product was applied or in the nearby skin over the entire period of administration. At the end of RT, nine patients (22%) presented G1, 31 (76%) G2, and one patient (2%) G3 skin toxicity (after 5 weeks). Seven and 20 patients reached skin maximum toxicity at the fourth week and after the seventh week, respectively. An increasing trend of median spectrophotometry scores along with skin toxicity grades was observed. A correlation between Skindex-16 scores and skin toxicity grade during treatment was found.
  
  
  
  Our study results suggest that Xonrid® is well tolerated, safe, and effective in minimizing and delaying high-grade radiation dermatitis in HNC patients.
authors.affiliation: Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Nicola Alessandro
authors.initials: NA
authors.lastname: Iacovelli
authors.affiliation: Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Naimo
authors.affiliation: Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Bonfantini
authors.affiliation: Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Cavallo
authors.affiliation: Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bossi
authors.affiliation: Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Fallai
authors.affiliation: Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Pignoli
authors.affiliation: Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Alfieri
authors.affiliation: Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Bergamini
authors.affiliation: Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Favales
authors.affiliation: Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Venezian 1, 20133, Milan, Italy. ester.orlandi@istitutotumori.mi.it.
authors.forename: Ester
authors.initials: E
authors.lastname: Orlandi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000150:complications* / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011855:Radiodermatitis / Q000517:prevention & control*
keywords: Head and neck cancer; Patient satisfaction; Radiation induced dermatitis; Skin toxicity; Xonrid®