{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T12:18:03Z","timestamp":1780575483531,"version":"3.54.1"},"reference-count":9,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2022,1,15]],"date-time":"2022-01-15T00:00:00Z","timestamp":1642204800000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Grants-in-Aid for Scientific Research of the Japan Society for the Promotion of Science","award":["20K10097"],"award-info":[{"award-number":["20K10097"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,12,16]]},"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>jRCTs071200013.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-056781","type":"journal-article","created":{"date-parts":[[2022,1,17]],"date-time":"2022-01-17T11:05:47Z","timestamp":1642417547000},"page":"e056781","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"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)"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4646-587X","authenticated-orcid":false,"given":"Sakiko","family":"Soutome","sequence":"first","affiliation":[{"name":"Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsunobu","family":"Otsuru","sequence":"additional","affiliation":[{"name":"Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maho","family":"Murata","sequence":"additional","affiliation":[{"name":"Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumiko","family":"Kawashita","sequence":"additional","affiliation":[{"name":"Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masako","family":"Yoshimatsu","sequence":"additional","affiliation":[{"name":"Oral Management Center, Nagasaki University Hospital, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madoka","family":"Funahara","sequence":"additional","affiliation":[{"name":"Kyushu Dental University, School of Oral Health, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiko","family":"Yamamura","sequence":"additional","affiliation":[{"name":"Department of Oral Surgery, Institute of Biomedical Sciences, Tokushima University Graduate School, Tokushima, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takumi","family":"Hasegawa","sequence":"additional","affiliation":[{"name":"Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine, Kobe, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin-ichi","family":"Yamada","sequence":"additional","affiliation":[{"name":"Department of Dentistry and Oral Surgery, Shinshu University School of Medicine, Matsumoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuka","family":"Kojima","sequence":"additional","affiliation":[{"name":"Department of Dentistry and Oral Surgery, Kansai Medical University, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirokazu","family":"Nakahara","sequence":"additional","affiliation":[{"name":"Department of Oral and Maxillofacial Surgery, Graduate School of Medicine, Osaka City University, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuyuki","family":"Shibuya","sequence":"additional","affiliation":[{"name":"Department of Oral and Maxillofacial Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Umeda","sequence":"additional","affiliation":[{"name":"Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiyuki","family":"Saito","sequence":"additional","affiliation":[{"name":"Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2022,1,17]]},"reference":[{"key":"2025121601070206000_12.1.e056781.1","unstructured":"NCCN clinical practice guidelines in oncology (NCCN Guidelines\u00ae). head and neck cancers. 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