title: Phase II multicenter trial of Caphosol for the reduction of mucositis in patients receiving radiation therapy for head and neck cancer.
abstract: OBJECTIVE
  We conducted a phase II multicenter study evaluating Caphosol in patients receiving head and neck radiation (H/N RT) +/- chemotherapy or biologic sensitizer.
  
  
  METHODS
  The primary endpoint of the study tested the rate of functional mucositis (WHO grade > or equal to 2) with the hypothesis that <75% of patients would develop > or equal to 2 mucositis with Caphosol compared with a historical rate of >90%. New methods were applied with higher than historic rigor. 5 Institutions were included in this study: Moffitt Cancer Center (MCC), MD Anderson Cancer Center (MDACC), Duke University Cancer Center (DUCC), University of Florida (UF) and Temple University Cancer Center (TUCC). Caphosol was taken by patients at least 4 times a day and up to 10 times per day commencing with day 1 of RT and for a total duration of 8 weeks after completion of RT. Detailed questionnaires were completed weekly by patients and a unique algorithm was used to generate the WHO grade of mucositis.
  
  
  RESULTS
  98 Patients were enrolled in the study. 59/98 (60%) patients were evaluable for the primary endpoint giving us 80% power. All evaluable patients experienced WHO grade > or equal to 2 mucositis and the trial failed to reject the null hypothesis. > or equal to 2 mucositis rates at weeks 2, 4, 6, 11 and 15 were as follows: 45%, 90%, 98%, 71%, 50%.
  
  
  CONCLUSIONS
  We were unable to demonstrate that Caphosol significantly reduced WHO grade 2 or higher mucositis below a 90% historic rate. We are not surprised with this finding given our rigorous methodology in grading.
authors: Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA. Electronic address: Nikhil.Rao@moffitt.org.
authors: Nikhil G
authors: NG
authors: Rao
authors: Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA.
authors: Andy
authors: A
authors: Trotti
authors: Department of Biostatistics, Moffitt Cancer Center, Tampa, FL, USA.
authors: Jongphil
authors: J
authors: Kim
authors: Department of Biostatistics, Moffitt Cancer Center, Tampa, FL, USA.
authors: Michael J
authors: MJ
authors: Schell
authors: Department of Biostatistics, Moffitt Cancer Center, Tampa, FL, USA.
authors: Xiuhua
authors: X
authors: Zhao
authors: Department of Radiation Oncology, University of Florida, Gainsville, FL, USA.
authors: Robert J
authors: RJ
authors: Amdur
authors: Department of Radiation Oncology, Duke University Cancer Center, Durham, NC, USA.
authors: David M
authors: DM
authors: Brizel
authors: Department of Onc Dentistry Prosthodontics, MD Anderson Cancer Center, Houston, TX, USA.
authors: Mark S
authors: MS
authors: Chambers
authors: Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL, USA.
authors: Jimmy J
authors: JJ
authors: Caudell
authors: Department of Radiation Oncology, Temple University Cancer Center, Philadelphia, PA, USA.
authors: Curtis
authors: C
authors: Miyamoto
authors: Department of Radiation Oncology, MD Anderson Cancer Center, Houston, TX, USA.
authors: David I
authors: DI
authors: Rosenthal
mesh_terms: D002130:Calcium Phosphates / Q000627:therapeutic use*; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D006982:Hypertonic Solutions / Q000627:therapeutic use*; D008297:Male; D052016:Mucositis / Q000188:drug therapy* / Q000209:etiology; D019999:Pharmaceutical Solutions / Q000627:therapeutic use*; D011878:Radiotherapy / Q000009:adverse effects
chemical_list: D002130:Calcium Phosphates; D006982:Hypertonic Solutions; D019999:Pharmaceutical Solutions
keywords: Caphosol; Head and neck cancer; Mucositis; Oral; Radiotherapy