Item type |
学術雑誌論文 / Journal Article(1) |
公開日 |
2022-03-01 |
タイトル |
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タイトル |
Preventive effects of betamethasone valerate ointment for radiation-induced severe oral mucositis in patients with oral or oropharyngeal cancer: protocol for a multicentre, phase II, randomised controlled trial (Bet-ROM study) |
言語 |
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言語 |
eng |
資源タイプ |
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資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
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資源タイプ |
journal article |
著者 |
Soutome, Sakiko
Otsuru, Mitsunobu
Murata, Maho
Kawashita, Yumiko
Yoshimatsu, Masako
Funahara, Madoka
Yamamura, Yoshiko
Hasegawa, Takumi
Yamada, Shin-ichi
Kojima, Yuka
Nakahara, Hirokazu
Shibuya, Yasuyuki
Umeda, Masahiro
Saito, Toshiyuki
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抄録 |
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内容記述タイプ |
Abstract |
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内容記述 |
Introduction: This is a randomised, multi-centre, open-label, phase II study to evaluate the efficacy of betamethasone valerate ointment on radiation-induced oral mucositis in patients with head and neck cancer undergoing concomitant radiotherapy with cisplatin or cetuximab. Methods and analysis: The trial will take place at seven hospitals in Japan. Patients will be randomised (1:1) into betamethasone and control groups after the occurrence of grade 1 oral mucositis. In the betamethasone group, patients will use betamethasone valerate ointment five times a day, in addition to usual oral hygiene guidance. The primary endpoint is the incidence and onset time of grade 3 oral mucositis. The secondary endpoints are the incidence and onset time of grade 2 oral mucositis, incidence and onset time of oral candidiasis, completion of radiation therapy and adverse events. Target accrual is 102 patients with a two-sided type I error rate of 5% and 80% power to detect an 80% risk reduction in the incidence of grade 3 oral mucositis. Ethics and dissemination: This study was approved by the Clinical Research Review Board of Nagasaki University (No. CRB20-009). All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publication. The datasets generated during the study will be available from the corresponding author on reasonable request. Trial registration number: jRCTs071200013. |
書誌情報 |
BMJ Open
巻 12,
号 1,
p. e056781,
発行日 2022-01-17
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出版者 |
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出版者 |
BMJ Publishing Group Ltd. |
ISSN |
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収録物識別子タイプ |
ISSN |
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収録物識別子 |
2044-6055 |
DOI |
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関連タイプ |
isIdenticalTo |
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識別子タイプ |
DOI |
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関連識別子 |
10.1136/bmjopen-2021-056781 |
権利 |
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権利情報 |
© Author(s) (or their employer(s)) 2022. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
著者版フラグ |
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出版タイプ |
VoR |
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出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
引用 |
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内容記述タイプ |
Other |
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内容記述 |
BMJ Open, 12(1), e056781; 2022 |