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
Journal
Radiation Oncology
Journal Volume
14
Journal Issue
1
Date Issued
2019-05-30
Author(s)
Chou, Hsiu Ling
Shueng, Pei Wei
Liao, Li Jen
Hsu, Chen Xiong
Kuo, Deng Yu
Lo, Wu Chia
Hou, Pei Yu
Chou, San Fang
Hsieh, Chen Hsi
Abstract
© 2019 The Author(s). Background: 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). Methods: Between 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. Results: No 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). Conclusions: NS-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 registration: The study was approved by the Institutional Review Board of Far Eastern Memorial Hospital (FEMH-IRB, 104048-F), Registered 1st June 2015,
Subjects
Head and neck cancer | NS-21 | Radiation dermatitis | Skin moisture | Skin toxicity
Head and neck cancer; NS-21; Radiation dermatitis; Skin moisture; Skin toxicity
SDGs
Other Subjects
cisplatin; fluorouracil; folinic acid; temiverine; dermatological agent; phenylacetic acid derivative; temiverine; adult; Article; cancer patient; chemoradiotherapy; clinical article; controlled study; dermatitis; disease severity; drug efficacy; drug safety; female; head and neck cancer; human; incidence; male; middle aged; pruritus; radiation dermatitis; radiation dose; randomized controlled trial; risk factor; skin; treatment duration; aged; head and neck tumor; intensity modulated radiation therapy; pathology; radiation dermatitis; radiotherapy dosage; treatment outcome; very elderly; Adult; Aged; Aged, 80 and over; Dermatologic Agents; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Phenylacetates; Radiodermatitis; Radiotherapy Dosage; Radiotherapy, Intensity-Modulated; Treatment Outcome
Publisher
BMC
Type
journal article