title: Multicenter phase II study of an oral care program for patients with head and neck cancer receiving chemoradiotherapy.
abstract: This multicenter phase II trial assessed the clinical benefit of a multidisciplinary oral care program in reducing the incidence of severe chemoradiotherapy-induced oral mucositis (OM).
  
  
  
  Patients with head and neck cancer (HNC) who were scheduled to receive definitive or postoperative chemoradiotherapy were enrolled. The oral care program included routine oral screening by dentists and a leaflet containing instructions regarding oral care, nutrition, and lifestyle. Oral hygiene and oral care were evaluated continuously during and after the course of chemoradiotherapy. The primary endpoint was the incidence of grade ≥3 OM assessed by certified medical staff according to the Common Terminology Criteria of Adverse Events version 3.0.
  
  
  
  From April 2012 to December 2013, 120 patients with HNC were enrolled. Sixty-four patients (53.3 %) developed grade ≥3 OM (i.e., functional/symptomatic). The incidence of grade ≤1 OM at 2 and 4 weeks after radiotherapy completion was 34.2 and 67.6 %, respectively. Clinical examination revealed that 51 patients (42.5 %) developed grade ≥3 OM during chemoradiotherapy. The incidence of grade ≤1 OM at 2 and 4 weeks after radiotherapy completion was 54.7 and 89.2 %, respectively. The incidences of grade 3 infection and pneumonitis throughout chemoradiotherapy were <5 %. Only 6.7 % of patients had unplanned breaks in radiotherapy, and 99.2 % completed treatment.
  
  
  
  A systematic oral care program alone is insufficient to decrease the incidence of severe OM in patients with HNC being treated with chemoradiotherapy. However, systematic oral care programs may indirectly improve treatment compliance by decreasing infection risk.
  
  
  
  UMIN000006660.
authors.affiliation: Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan. t.yokota@scchr.jp.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Yokota
authors.affiliation: Division of Radiation Oncology, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Tachibana
authors.affiliation: Division of Dentistry, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
authors.forename: Tetsuhito
authors.initials: T
authors.lastname: Konishi
authors.affiliation: Division of Dental and Oral Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yurikusa
authors.affiliation: Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Hamauchi
authors.affiliation: Sakai Dental Clinic, 6-7 Hayato-cho, Showa-ku, Nagoya, 466-0833, Japan.
authors.forename: Kensuke
authors.initials: K
authors.lastname: Sakai
authors.affiliation: Oral and Maxillofacial Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.
authors.forename: Masaya
authors.initials: M
authors.lastname: Nishikawa
authors.affiliation: Division of Dental and Oral Surgery, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
authors.forename: Miho
authors.initials: M
authors.lastname: Suzuki
authors.affiliation: Division of Dentistry, Head and Neck Surgery, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
authors.forename: Yayoi
authors.initials: Y
authors.lastname: Naganawa
authors.affiliation: Division of Pharmacy, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
authors.forename: Tomoka
authors.initials: T
authors.lastname: Hagihara
authors.affiliation: Department of Nursing, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Tsumaki
authors.affiliation: Department of Nursing, Aichi Cancer Center Hospital, 1-1, Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
authors.forename: Tomo
authors.initials: T
authors.lastname: Kubo
authors.affiliation: Department of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
authors.forename: Maho
authors.initials: M
authors.lastname: Sato
authors.affiliation: Department of Biostatistics and Epidemiology, Graduate School of Medicine, Yokohama City University, 3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.
authors.forename: Masataka
authors.initials: M
authors.lastname: Taguri
authors.affiliation: Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Sunstar Shizuoka Institute, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Eguchi
authors.affiliation: Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School Hospital Cancer Center, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kubota
authors.affiliation: Division of Radiation Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
authors.forename: Sadamoto
authors.initials: S
authors.lastname: Zenda
mesh_terms: D000328:Adult; D000368:Aged; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013280:Stomatitis / Q000209:etiology* / Q000628:therapy*; D055815:Young Adult
keywords: Chemoradiotherapy; Head and neck cancer; Multidisciplinary; Oral care; Oral mucositis