title: Multi-institutional, randomized, double-blind, placebo-controlled trial to assess the efficacy of a mucoadhesive hydrogel (MuGard) in mitigating oral mucositis symptoms in patients being treated with chemoradiation therapy for cancers of the head and neck.
abstract: BACKGROUND
  The objective of this trial was to determine how a mucoadhesive hydrogel (MuGard), a marketed medical device, would fare when tested with the strictness of a conventional multi-institutional, double-blind, randomized, placebo-controlled study format.
  
  
  METHODS
  A total of 120 subjects planned to receive chemoradiation therapy (CRT) for treatment of head and neck cancers were randomized to receive either MuGard or sham control rinse (SC) during CRT. Subjects completed the validated Oral Mucositis Daily Questionnaire. Weight, opiate use, and World Health Organization (WHO) oral mucositis (OM) scores were recorded. Subjects who dosed at least once daily during the first 2.5 weeks of CRT were included in the efficacy analysis.
  
  
  RESULTS
  Of 120 subjects enrolled, 78 (SC, N=41; MuGard, N=37) were eligible for efficacy analysis. Both cohorts were similar in demographics, baseline characteristics, primary tumor type, and planned CRT regimen. MuGard effectively mitigated OM symptoms as reflected by area under the curve of daily patient-reported oral soreness (P=.034) and WHO scores on the last day of radiation therapy (P=.038). MuGard was also associated with nonsignificant trends related to therapeutic benefit including opioid use duration, and OM scores (WHO criteria) at CRT week 4. Rinse compliance was identical between cohorts. No significant adverse events were reported, and the adverse event incidence was similar between cohorts.
  
  
  CONCLUSIONS
  Testing MuGard, a rinse marketed as a device, in a standard clinical trial format demonstrated its superiority to SC in mitigating OM symptoms, delaying OM progression, and its safety and tolerability.
authors.forename: Ron R
authors.initials: RR
authors.lastname: Allison
authors.forename: Aaron A
authors.initials: AA
authors.lastname: Ambrad
authors.forename: Youssef
authors.initials: Y
authors.lastname: Arshoun
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Carmel
authors.forename: Doug F
authors.initials: DF
authors.lastname: Ciuba
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Feldman
authors.forename: Steven E
authors.initials: SE
authors.lastname: Finkelstein
authors.forename: Ranjini
authors.initials: R
authors.lastname: Gandhavadi
authors.forename: Dwight E
authors.initials: DE
authors.lastname: Heron
authors.forename: Steven C
authors.initials: SC
authors.lastname: Lane
authors.forename: John M
authors.initials: JM
authors.lastname: Longo
authors.forename: Charles
authors.initials: C
authors.lastname: Meakin
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Papadopoulos
authors.forename: David E
authors.initials: DE
authors.lastname: Pruitt
authors.forename: Lynn M
authors.initials: LM
authors.lastname: Steinbrenner
authors.forename: Michael A
authors.initials: MA
authors.lastname: Taylor
authors.forename: William M
authors.initials: WM
authors.lastname: Wisbeck
authors.forename: Grace E
authors.initials: GE
authors.lastname: Yuh
authors.forename: David P
authors.initials: DP
authors.lastname: Nowotnik
authors.forename: Stephen T
authors.initials: ST
authors.lastname: Sonis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000473:pathology / Q000528:radiation effects; D009367:Neoplasm Staging; D010919:Placebos; D000077195:Squamous Cell Carcinoma of Head and Neck; D013280:Stomatitis / Q000188:drug therapy* / Q000209:etiology*
chemical_list: D010919:Placebos; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate