{"created":"2023-05-15T16:49:37.329738+00:00","id":27137,"links":{},"metadata":{"_buckets":{"deposit":"4087738d-b068-4b65-b4c5-b0ddd75b20fc"},"_deposit":{"created_by":6,"id":"27137","owners":[6],"pid":{"revision_id":0,"type":"depid","value":"27137"},"status":"published"},"_oai":{"id":"oai:nagasaki-u.repo.nii.ac.jp:00027137","sets":["10:11"]},"author_link":["121004","121010","120999","121002","121006","121005","121008","121003","121007","121012","121000","121009","121001","121011"],"item_2_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2022-01-17","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1","bibliographicPageStart":"e056781","bibliographicVolumeNumber":"12","bibliographic_titles":[{"bibliographic_title":"BMJ Open"}]}]},"item_2_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"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.\nMethods 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.\nEthics 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.\nTrial registration number: jRCTs071200013.","subitem_description_type":"Abstract"}]},"item_2_description_63":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"BMJ Open, 12(1), e056781; 2022","subitem_description_type":"Other"}]},"item_2_publisher_33":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"BMJ Publishing Group Ltd."}]},"item_2_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1136/bmjopen-2021-056781","subitem_relation_type_select":"DOI"}}]},"item_2_rights_13":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"© 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/."}]},"item_2_source_id_7":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"2044-6055","subitem_source_identifier_type":"ISSN"}]},"item_2_version_type_16":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Soutome, Sakiko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Otsuru, Mitsunobu"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Murata, Maho"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kawashita, Yumiko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yoshimatsu, Masako"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Funahara, Madoka"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yamamura, Yoshiko"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Hasegawa, Takumi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yamada, Shin-ichi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kojima, Yuka"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Nakahara, Hirokazu"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Shibuya, Yasuyuki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Umeda, Masahiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Saito, Toshiyuki"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2022-03-01"}],"displaytype":"detail","filename":"BMJO12_e056781.pdf","filesize":[{"value":"644.2 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"BMJO12_e056781.pdf","url":"https://nagasaki-u.repo.nii.ac.jp/record/27137/files/BMJO12_e056781.pdf"},"version_id":"c60e777b-6462-412a-9de8-55821782dd72"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"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)","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"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)"}]},"item_type_id":"2","owner":"6","path":["11"],"pubdate":{"attribute_name":"公開日","attribute_value":"2022-03-01"},"publish_date":"2022-03-01","publish_status":"0","recid":"27137","relation_version_is_last":true,"title":["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)"],"weko_creator_id":"6","weko_shared_id":-1},"updated":"2023-05-15T19:56:55.156880+00:00"}