title: A randomised controlled trial of Caphosol mouthwash in management of radiation-induced mucositis in head and neck cancer.
abstract: This phase III, non-blinded, parallel-group, randomised controlled study evaluated the efficacy of Caphosol mouthwash in the management of radiation-induced oral mucositis (OM) in patients with head and neck cancer (HNC) undergoing radical (chemo)radiotherapy.
  
  
  
  Eligible patients were randomised at 1:1 to Caphosol plus standard oral care (intervention) or standard oral care alone (control), stratified by radiotherapy technique and use of concomitant chemotherapy. Patients in the intervention arm used Caphosol for 7weeks: 6weeks during and 1-week post-radiotherapy. The primary endpoint was the incidence of severe OM (CTCAE ⩾grade 3) during and up to week 8 post-radiotherapy. Secondary endpoints include pharyngeal mucositis, dysphagia, pain and quality of life.
  
  
  
  The intervention (n=108) and control (n=107) arms were well balanced in terms of patient demographics and treatment characteristics. Following exclusion of patients with missing data, 210 patients were available for analysis. The incidence of severe OM did not differ between the intervention and control arms (64.1% versus 65.4%, p=0.839). Similarly, no significant benefit was observed for other secondary endpoints. Overall, compliance with the recommended frequency of Caphosol was low.
  
  
  
  Caphosol did not reduce the incidence or duration of severe OM during and after radiotherapy in HNC.
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, Sutton, UK; The Institute of Cancer Research, London, UK. Electronic address: kee.wong@icr.ac.uk.
authors.forename: Kee H
authors.initials: KH
authors.lastname: Wong
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, Sutton, UK.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Kuciejewska
authors.affiliation: Clinical Statistics Unit, Royal Marsden Hospital, Sutton, UK.
authors.forename: Mansour T A
authors.initials: MTA
authors.lastname: Sharabiani
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, Sutton, UK.
authors.forename: Brian
authors.initials: B
authors.lastname: Ng-Cheng-Hin
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, Sutton, UK.
authors.forename: Sonja
authors.initials: S
authors.lastname: Hoy
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, Sutton, UK.
authors.forename: Tara
authors.initials: T
authors.lastname: Hurley
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, Sutton, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Rydon
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, London, UK.
authors.forename: Lorna
authors.initials: L
authors.lastname: Grove
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, London, UK.
authors.forename: Ana
authors.initials: A
authors.lastname: Santos
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, London, UK.
authors.forename: Motoko
authors.initials: M
authors.lastname: Ryugenji
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, Sutton, UK; The Institute of Cancer Research, London, UK.
authors.forename: Shreerang A
authors.initials: SA
authors.lastname: Bhide
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.
authors.forename: Chris M
authors.initials: CM
authors.lastname: Nutting
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, London, UK; The Institute of Cancer Research, London, UK.
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Harrington
authors.affiliation: Head and Neck Oncology Unit, Royal Marsden Hospital, Sutton, UK; The Institute of Cancer Research, London, UK. Electronic address: Kate.newbold@rmh.nhs.uk.
authors.forename: Kate L
authors.initials: KL
authors.lastname: Newbold
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006258:Head and Neck Neoplasms / Q000523:psychology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000627:therapeutic use*; D011788:Quality of Life; D011832:Radiation Injuries / Q000453:epidemiology / Q000628:therapy*; D013280:Stomatitis / Q000453:epidemiology / Q000628:therapy*
chemical_list: D009067:Mouthwashes
keywords: Caphosol; Head and neck cancer; Mucositis; Radiotherapy