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
| Autor: | Michael A. Taylor, Dimitrios Papadopoulos, David E. Pruitt, Charles J. Meakin, Doug F. Ciuba, David P. Nowotnik, Dwight E. Heron, Grace E. Yuh, Ranjini Gandhavadi, Youssef Arshoun, Aaron A. Ambrad, Richard J. Carmel, William M. Wisbeck, Stephen T. Sonis, Ron R. Allison, Steven E. Finkelstein, Elizabeth Feldman, Steven C. Lane, John M. Longo, Lynn M. Steinbrenner |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Placebo-controlled study Hydrogel Polyethylene Glycol Dimethacrylate Symptom Control and Palliative Care law.invention Placebos Discipline Randomized controlled trial Double-Blind Method law Internal medicine medicine Mucositis Humans Adverse effect chemoradiation Aged Neoplasm Staging Aged 80 and over Stomatitis business.industry Squamous Cell Carcinoma of Head and Neck Mouth Mucosa mucoadhesive gel Chemoradiotherapy Original Articles Middle Aged medicine.disease Surgery Clinical trial Regimen mucositis Oncology Tolerability Head and Neck Neoplasms Carcinoma Squamous Cell Female Original Article head and neck cancer business |
| Zdroj: | Cancer |
| ISSN: | 1097-0142 |
| Popis: | 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. In a randomized, double‐blind, placebo‐controlled trial, the mucoadhesive hydrogel MuGard proved to be superior to saline‐bicarbonate rinse in mitigating oral mucositis (OM) symptoms and delaying OM progression. MuGard was safe and well‐tolerated, and favorably affected the rate and incidence of ulcerative lesions, consistent with the patient‐reported outcomes. |
| Databáze: | OpenAIRE |
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