Prophylactic NS-21 maintains the skin moisture but does not reduce the severity of radiation dermatitis in patients with head and neck cancer: a randomized control trial

Hsiu-Ling Chou,Chen-Xiong Hsu,Li-Jen Liao,Chen-Hsi Hsieh,Wu-Chia Lo,Pei-Yu Hou,San-Fang Chou,Li-Ying Wang,Pei-Wei Shueng,Deng-Yu Kuo

doi:10.1186/s13014-019-1302-4

Abstract

BackgroundTo evaluate the practicality of NS-21 cream with regard to its skin-related toxicity in patients with head and neck cancer (HNC) who are undergoing concurrent chemoradiation therapy (CCRT) or radiotherapy (RT).MethodsBetween July 2015 and November 2017, 30 HNC patients who underwent RT or CCRT were randomly allocated to receive either NS-21 or control treatment on their irradiated skin three times per day, starting at the initiation of RT or CCRT and ending 2 weeks after the completion of RT or until the appearance of grade 3 acute radiation dermatitis (ARD). Dermatitis was recorded weekly according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Skin humidity was monitored by a digital moisture meter. The generalized estimating equation (GEE) and logit link function method were used for statistical analysis.ResultsNo serious adverse events were observed in either group. Itching dermatitis occurred on the right lower neck in one patient of the NS-21 group during the 3rd week of CCRT, but the severity was mild. The median skin moisture value at the time of the final treatment was significantly different between the study and control groups (30.6 vs. 27.3, p = 0.013). Additionally, there was an inverse relationship between skin moisture and ARD grade (B = -0.04, p = 0.005). The incidence of ARD at the time of the last treatment was not significantly different between the study and control groups (6.7% vs 26.7%, p = 0.165). The risk of grade 3 ARD for skin that had received an irradiation dose of 47–70 Gy was higher than that of skin that had received an irradiation dose ≤46 Gy (OR = 31.06, 95% CI =5.95–162.21, p < 0.001). Nevertheless, the risk of ARD was not significantly different between the groups (OR = 0.38, 95% CI = 0.08–1.74, p = 0.212).ConclusionsNS-21 was well tolerated and effective for the maintenance of skin moisture; however, there was no statistically significant reduction in the risk of ARD in HNC patients undergoing RT or CCRT when compared with HNC patients in the control group.Trial registrationThe study was approved by the Institutional Review Board of Far Eastern Memorial Hospital (FEMH-IRB, 104048-F), Registered 1st June 2015,

Highlights

14–25% of head and neck cancer (HNC) patients experience severe acute radiation dermatitis (ARD) reactions [1, 2]
This study aimed to demonstrate the safety and efficacy of NS-21 as a prophylactic agent during concurrent chemoradiation therapy (CCRT) or RT for patients with HNC to prevent grade 3 or higher ARD during the treatment period
Of the 39 patients, 19 and 20 patients were randomly assigned to the NS-21 and control groups, respectively (Fig. 1)

Summary

Introduction

14–25% of head and neck cancer (HNC) patients experience severe acute radiation dermatitis (ARD) reactions [1, 2]. There are no recognized standard treatments that have been recommended for the prevention of ARD in HNC patients. Several topical agents, such as Aloe vera gel [4], topical cortisone cream [5], trolamine (Biafine) [6], and hyaluronic acid cream [5], have been applied to prevent skin dermatitis. To evaluate the practicality of NS-21 cream with regard to its skin-related toxicity in patients with head and neck cancer (HNC) who are undergoing concurrent chemoradiation therapy (CCRT) or radiotherapy (RT)

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