title: Evaluation of oral care to prevent oral mucositis in estrogen receptor-positive metastatic breast cancer patients treated with everolimus (Oral Care-BC): randomized controlled phase III trial.
abstract: This is a randomized, multi-center, open-label, phase III study to evaluate the efficacy of professional oral care in preventing oral mucositis induced by everolimus in postmenopausal estrogen receptor-positive metastatic breast cancer. Patients will be randomized into professional oral care and control groups (1:1 ratio). All patients will receive everolimus with exemestane and will continue everolimus until disease progression. In the professional oral care group, patients will receive teeth surface cleaning, scaling and tongue cleaning before starting everolimus, and will continue to receive professional oral care weekly from oral surgeons throughout the 8 week treatment. In the control group, patients will brush their own teeth and gargle with 0.9% sodium chloride solution or water. The primary endpoint is the incidence of all grades of oral mucositis. Target accrual is 200 patients with a two-sided type I error rate of 5% and 80% power to detect 25% risk reduction.
authors.affiliation: Departments of Breast and Endocrine Surgery, Tokai University School of Medicine, Ishehara niikura@is.icc.u-tokai.ac.jp.
authors.forename: Naoki
authors.initials: N
authors.lastname: Niikura
authors.affiliation: Dentistry and Oral and Maxillofacial Surgery, Tokai University School of Medicine, Ishehara.
authors.forename: Yoshihide
authors.initials: Y
authors.lastname: Ota
authors.affiliation: Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo.
authors.forename: Naoki
authors.initials: N
authors.lastname: Hayashi
authors.affiliation: Department of Preventive Medicine, Nagoya University Graduate School of Medicine, Nagoya.
authors.forename: Mariko
authors.initials: M
authors.lastname: Naito
authors.affiliation: Department of Biostatistics, School of Public Health, The University of Tokyo, Tokyo.
authors.forename: Kosuke
authors.initials: K
authors.lastname: Kashiwabara
authors.affiliation: Department of Breast Surgery, Hokkaido Cancer Center, Hokkaido.
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Watanabe
authors.affiliation: Department of Breast Surgical Oncology, Cancer and Infectious Diseases Center Tokyo Metropolitan Komagome Hospital, Tokyo.
authors.forename: Toshinari
authors.initials: T
authors.lastname: Yamashita
authors.affiliation: Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Mukai
authors.affiliation: Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Umeda
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008875:Middle Aged; D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000378:metabolism / Q000473:pathology; D004359:Drug Therapy, Combination; D000068338:Everolimus / Q000009:adverse effects / Q000627:therapeutic use; D011960:Receptors, Estrogen / Q000378:metabolism; D012720:Severity of Illness Index; D012965:Sodium Chloride / Q000627:therapeutic use; D013280:Stomatitis / Q000473:pathology / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic; D017326:Clinical Trials, Phase III as Topic; D012107:Research Design
chemical_list: D000730:Androstadienes; D000970:Antineoplastic Agents; D000068338:Everolimus; C056516:exemestane; D011960:Receptors, Estrogen; D012965:Sodium Chloride
keywords: breast cancer; everolimus; oral care