title: The effect of a supersaturated calcium phosphate mouth rinse on the development of oral mucositis in head and neck cancer patients treated with (chemo)radiation: a single-center, randomized, prospective study of a calcium phosphate mouth rinse + standard of care versus standard of care.
abstract: OBJECTIVE
  Mucosal damage is an important and debilitating side effect when treating head and neck cancer patients with (chemo-)radiation. The aim of this randomized clinical trial was to investigate whether the addition of a neutral, supersaturated, calcium phosphate (CP) mouth rinse benefits the severity and duration of acute mucositis in head and neck cancer patients treated with (chemo)radiation.
  
  
  METHODS
  A total of 60 patients with malignant neoplasms of the head and neck receiving (chemo)radiation were included in this study. Fifty-eight patients were randomized into two treatment arms: a control group receiving standard of care (n = 31) and a study group receiving standard of care + daily CP mouth rinses (n = 27) starting on the first day of (chemo-)radiation. Oral mucositis and dysphagia were assessed twice a week using the National Cancer Institute common toxicity criteria scale version 3, oral pain was scored with a visual analogue scale.
  
  
  RESULTS
  No significant difference in grade III mucositis (59 vs. 71 %; p = 0.25) and dysphagia (33 vs. 42 %, p = 0.39) was observed between the study group compared to the control group. Also no significant difference in time until development of peak mucositis (28.6 vs. 28.7 days; p = 0.48), duration of peak mucositis (22.7 vs. 24.6 days; p = 0.31), recuperation of peak dysphagia (20.5 vs 24.2 days; p = 0.13) and occurrence of severe pain (56 vs. 52 %, p = 0.5).
  
  
  CONCLUSIONS
  In this randomized study, the addition of CP mouth rinse to standard of care did not improve the frequency, duration or severity of the most common acute toxicities during and early after (chemo)radiation. There is currently no evidence supporting its standard use in daily practice.
authors.affiliation: Department of Radiation-Oncology, University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium.
authors.forename: Maarten
authors.initials: M
authors.lastname: Lambrecht
authors.forename: Carole
authors.initials: C
authors.lastname: Mercier
authors.forename: Yasmyne
authors.initials: Y
authors.lastname: Geussens
authors.forename: Sandra
authors.initials: S
authors.lastname: Nuyts
mesh_terms: D000328:Adult; D000368:Aged; D002130:Calcium Phosphates / Q000008:administration & dosage*; D059248:Chemoradiotherapy / Q000009:adverse effects; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000528:radiation effects; D009067:Mouthwashes / Q000008:administration & dosage; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D011446:Prospective Studies; D011832:Radiation Injuries / Q000188:drug therapy / Q000209:etiology; D059039:Standard of Care; D013280:Stomatitis / Q000139:chemically induced / Q000188:drug therapy*
chemical_list: D002130:Calcium Phosphates; D009067:Mouthwashes; C020243:calcium phosphate