RT Journal Article SR Electronic T1 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) JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e056781 DO 10.1136/bmjopen-2021-056781 VO 12 IS 1 A1 Sakiko Soutome A1 Mitsunobu Otsuru A1 Maho Murata A1 Yumiko Kawashita A1 Masako Yoshimatsu A1 Madoka Funahara A1 Yoshiko Yamamura A1 Takumi Hasegawa A1 Shin-ichi Yamada A1 Yuka Kojima A1 Hirokazu Nakahara A1 Yasuyuki Shibuya A1 Masahiro Umeda A1 Toshiyuki Saito YR 2022 UL http://bmjopen.bmj.com/content/12/1/e056781.abstract AB 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.