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 language | English |
|---|---|
| Pages (from-to) | 1787-1795 |
| Number of pages | 9 |
| Journal | Supportive Care in Cancer |
| Volume | 25 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - Jun 1 2017 |
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Keywords
- Head and neck cancer
- Patient satisfaction
- Radiation induced dermatitis
- Skin toxicity
- Xonrid®
ASJC Scopus subject areas
- Oncology
Cite this
Preemptive treatment with Xonrid®, a medical device to reduce radiation induced dermatitis in head and neck cancer patients receiving curative treatment : a pilot study. / Iacovelli, Nicola Alessandro; Naimo, Simona; Bonfantini, Francesca; Cavallo, Anna; Bossi, Paolo; Fallai, Carlo; Pignoli, Emanuele; Alfieri, Salvatore; Bergamini, Cristiana; Favales, Federica; Orlandi, Ester.
In: Supportive Care in Cancer, Vol. 25, No. 6, 01.06.2017, p. 1787-1795.Research output: Contribution to journal › Article
}
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®
UR - http://www.scopus.com/inward/record.url?scp=85009836785&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85009836785&partnerID=8YFLogxK
U2 - 10.1007/s00520-017-3569-z
DO - 10.1007/s00520-017-3569-z
M3 - Article
C2 - 28108819
AN - SCOPUS:85009836785
VL - 25
SP - 1787
EP - 1795
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
SN - 0941-4355
IS - 6
ER -