Phase II multicenter trial of Caphosol for the reduction of mucositis in patients receiving radiation therapy for head and neck cancer.

Journal Article (Journal Article;Multicenter Study)

PURPOSE: We conducted a phase II multicenter study evaluating Caphosol in patients receiving head and neck radiation (H/N RT) +/- chemotherapy or biologic sensitizer. MATERIALS/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%. CONCLUSION: 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.

Full Text

Duke Authors

Cited Authors

  • Rao, NG; Trotti, A; Kim, J; Schell, MJ; Zhao, X; Amdur, RJ; Brizel, DM; Chambers, MS; Caudell, JJ; Miyamoto, C; Rosenthal, DI

Published Date

  • August 2014

Published In

Volume / Issue

  • 50 / 8

Start / End Page

  • 765 - 769

PubMed ID

  • 24954065

Pubmed Central ID

  • PMC4593395

Electronic International Standard Serial Number (EISSN)

  • 1879-0593

Digital Object Identifier (DOI)

  • 10.1016/j.oraloncology.2014.06.001


  • eng

Conference Location

  • England