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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
Author(s) -
Allison Ron R.,
Ambrad Aaron A.,
Arshoun Youssef,
Carmel Richard J.,
Ciuba Doug F.,
Feldman Elizabeth,
Finkelstein Steven E.,
Gandhavadi Ranjini,
Heron Dwight E.,
Lane Steven C.,
Longo John M.,
Meakin Charles,
Papadopoulos Dimitrios,
Pruitt David E.,
Steinbrenner Lynn M.,
Taylor Michael A.,
Wisbeck William M.,
Yuh Grace E.,
Nowotnik David P.,
Sonis Stephen T.
Publication year - 2014
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.28553
Subject(s) - medicine , mucositis , adverse effect , placebo , tolerability , randomized controlled trial , head and neck cancer , regimen , clinical trial , dysgeusia , cancer , radiation therapy , physical therapy , alternative medicine , pathology
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. Cancer 2014;120:1433–1440 . © 2014 Access Pharmaceuticals, Inc. Cancer published by Wiley Periodicals. Inc. on behalf of American Cancer Society.