@article{oai:nagasaki-u.repo.nii.ac.jp:00027137,
 author = {Soutome, Sakiko and Otsuru, Mitsunobu and Murata, Maho and Kawashita, Yumiko and Yoshimatsu, Masako and Funahara, Madoka and Yamamura, Yoshiko and Hasegawa, Takumi and Yamada, Shin-ichi and Kojima, Yuka and Nakahara, Hirokazu and Shibuya, Yasuyuki and Umeda, Masahiro and Saito, Toshiyuki},
 issue = {1},
 journal = {BMJ Open},
 month = {Jan},
 note = {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., BMJ Open, 12(1), e056781; 2022},
 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)},
 volume = {12},
 year = {2022}
}