Evidence map›Paper›PMID 31146741›Full record

Trial reportRadiation oncology (London, England)2019

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

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Radiation oncology (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Hsiu-Ling ChouDepartment of Nursing, Far Eastern Memorial Hospital, New Taipei City, Taiwan.
Pei-Wei ShuengDivision of Radiation Oncology, Department of Radiology, Far Eastern Memorial Hospital, 21 Sec 2, Nanya S Road, Banciao District, New Taipei City, 220, Taiwan.
Li-Jen LiaoDepartment of Otolaryngology Head and Neck Surgery, Far Eastern Memorial Hospital, Taipei, Taiwan.
Chen-Xiong HsuDivision of Radiation Oncology, Department of Radiology, Far Eastern Memorial Hospital, 21 Sec 2, Nanya S Road, Banciao District, New Taipei City, 220, Taiwan.
Deng-Yu KuoDivision of Radiation Oncology, Department of Radiology, Far Eastern Memorial Hospital, 21 Sec 2, Nanya S Road, Banciao District, New Taipei City, 220, Taiwan.
Wu-Chia LoDepartment of Otolaryngology Head and Neck Surgery, Far Eastern Memorial Hospital, Taipei, Taiwan.
Pei-Yu HouDivision of Radiation Oncology, Department of Radiology, Far Eastern Memorial Hospital, 21 Sec 2, Nanya S Road, Banciao District, New Taipei City, 220, Taiwan.
Li-Ying WangSchool and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.
San-Fang ChouDepartment of Medical Research, Far Eastern Memorial Hospital, New Taipei City, Taiwan.
Chen-Hsi HsiehDivision of Radiation Oncology, Department of Radiology, Far Eastern Memorial Hospital, 21 Sec 2, Nanya S Road, Banciao District, New Taipei City, 220, Taiwan. chenciab@gmail.com.ORCID http://orcid.org/0000-0003-0279-4695
Far Eastern Memorial Hospital · TWNational Yang Ming Chiao Tung University · TWAsia Eastern University of Science and Technology · TWNational Taiwan University · TW

Funding

Far Eastern Memorial Hospital FEMH-2018-C-010Ministry of Science and Technology, Taiwan MOST 102-2314-B-418-001; MOST 102-2314-B-418-002
6 · The paper itself

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.

Indexed as

AdultAgedAged, 80 and overDermatologic AgentsFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedPhenylacetatesRadiodermatitisRadiotherapy DosageRadiotherapy, Intensity-ModulatedTreatment OutcomeDermatologic AgentsPhenylacetatestemiverineHead and neck cancerNS-21Radiation dermatitisSkin moistureSkin toxicity

Identifiers

PMID31146741
PMCPMC6543645
OpenAlexW2947414727

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.