Preemptive treatment with Xonrid®, a medical device to reduce radiation induced dermatitis in head and neck cancer patients receiving curative treatment

a pilot study

Nicola Alessandro Iacovelli, Simona Naimo, Francesca Bonfantini, Anna Cavallo, Paolo Bossi, Carlo Fallai, Emanuele Pignoli, Salvatore Alfieri, Cristiana Bergamini, Federica Favales, Ester Orlandi

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Purpose: 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). Methods: 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. Results: 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. Conclusions: Our study results suggest that Xonrid® is well tolerated, safe, and effective in minimizing and delaying high-grade radiation dermatitis in HNC patients.

Original languageEnglish
Pages (from-to)1787-1795
Number of pages9
JournalSupportive Care in Cancer
Volume25
Issue number6
DOIs
Publication statusPublished - Jun 1 2017

Fingerprint

Radiodermatitis
Head and Neck Neoplasms
Equipment and Supplies
Skin
Radiotherapy
Therapeutics
Spectrophotometry
Dermatitis
Patient Satisfaction
Terminology
Prospective Studies

Keywords

  • Head and neck cancer
  • Patient satisfaction
  • Radiation induced dermatitis
  • Skin toxicity
  • Xonrid®

ASJC Scopus subject areas

  • Oncology

Cite this

@article{3e3c72ba6ca445408bf14617faf27224,
title = "Preemptive treatment with Xonrid{\circledR}, a medical device to reduce radiation induced dermatitis in head and neck cancer patients receiving curative treatment: a pilot study",
abstract = "Purpose: The purpose of this study was to investigate efficacy, safety and tolerability of Xonrid{\circledR}, a new medical device, in preventing radiation dermatitis associated with head and neck cancer (HNC) radiotherapy (RT). Methods: 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{\circledR} 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. Results: 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. Conclusions: Our study results suggest that Xonrid{\circledR} is well tolerated, safe, and effective in minimizing and delaying high-grade radiation dermatitis in HNC patients.",
keywords = "Head and neck cancer, Patient satisfaction, Radiation induced dermatitis, Skin toxicity, Xonrid{\circledR}",
author = "Iacovelli, {Nicola Alessandro} and Simona Naimo and Francesca Bonfantini and Anna Cavallo and Paolo Bossi and Carlo Fallai and Emanuele Pignoli and Salvatore Alfieri and Cristiana Bergamini and Federica Favales and Ester Orlandi",
year = "2017",
month = "6",
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doi = "10.1007/s00520-017-3569-z",
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pages = "1787--1795",
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TY - JOUR

T1 - Preemptive treatment with Xonrid®, a medical device to reduce radiation induced dermatitis in head and neck cancer patients receiving curative treatment

T2 - a pilot study

AU - Iacovelli, Nicola Alessandro

AU - Naimo, Simona

AU - Bonfantini, Francesca

AU - Cavallo, Anna

AU - Bossi, Paolo

AU - Fallai, Carlo

AU - Pignoli, Emanuele

AU - Alfieri, Salvatore

AU - Bergamini, Cristiana

AU - Favales, Federica

AU - Orlandi, Ester

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Purpose: 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). Methods: 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. Results: 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. Conclusions: Our study results suggest that Xonrid® is well tolerated, safe, and effective in minimizing and delaying high-grade radiation dermatitis in HNC patients.

AB - Purpose: 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). Methods: 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. Results: 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. Conclusions: Our study results suggest that Xonrid® is well tolerated, safe, and effective in minimizing and delaying high-grade radiation dermatitis in HNC patients.

KW - Head and neck cancer

KW - Patient satisfaction

KW - Radiation induced dermatitis

KW - Skin toxicity

KW - Xonrid®

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U2 - 10.1007/s00520-017-3569-z

DO - 10.1007/s00520-017-3569-z

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VL - 25

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JO - Supportive Care in Cancer

JF - Supportive Care in Cancer

SN - 0941-4355

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