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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)
http://hdl.handle.net/10069/00041298
http://hdl.handle.net/10069/00041298eec163a0-577a-4790-bf1b-da185609429d
名前 / ファイル | ライセンス | アクション |
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BMJO12_e056781.pdf (644.2 kB)
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2022-03-01 | |||||
タイトル | ||||||
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 | ||||||
言語 | eng | |||||
資源タイプ | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
著者 |
Soutome, Sakiko
× 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 | ||||||
内容記述タイプ | Abstract | |||||
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. |
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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 | ||||||
出版者 | BMJ Publishing Group Ltd. | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 2044-6055 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | 10.1136/bmjopen-2021-056781 | |||||
権利 | ||||||
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 | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
引用 | ||||||
内容記述タイプ | Other | |||||
内容記述 | BMJ Open, 12(1), e056781; 2022 |