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.

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.

Pacemaker/implantable cardioverter-defibrillator dose in balloon high-dose-rate brachytherapy for breast cancer treatment.

PURPOSE: To retrospectively report pacemaker (PM)/implantable cardioverter-defibrillator (ICD) dose in balloon high-dose-rate (HDR) brachytherapy and provide distance-dose graph and table to approximately estimate the maximal device dose. METHODS AND MATERIALS: For 3 patients (A, B, and C), PM/ICD was retrospectively contoured on planning computed tomography images and its maximal dose was extracted from a dose-volume histogram. The surface of 1cm expansion from balloon was prescribed to 34Gy and the inverse square law was dominant factor in dose calculation. Therefore, the maximal PM/ICD dose was approximately estimated from the distance-dose graph or table and compared with that of the treatment plan. RESULTS: The minimal device-balloon surface distance was 10.9, 18.4, and 4.3cm for patient A, B, and C, respectively. The maximal dose estimated from the proposed table/graph was 2.1 vs. 1.61Gy for patient A, 0.87 vs. 0.49Gy for patient B, and 8.9 vs. 9.14Gy for patient C compared with that from the treatment plan. CONCLUSIONS: Depending on the location of PM/ICD relative to the tumor bed, balloon HDR brachytherapy is feasible if the maximal dose is less than or equal to the dose limit. The proposed distance-dose graph and/or table enable to approximately predict the maximal device dose based on the measurement of minimal distance between lumpectomy and the device before balloon implantation for the suitability of balloon HDR brachytherapy.