Tolerability and Safety of a New Oral Device for Enhancing Prevention and Treatment of Oral Mucositis in a Group of Patients with Hematologic Malignancies Undergoing Chemotherapy
Authors: Oganesyan Artem , Harutyunyan Lusine , Vanoyan Araksya , Martirosyan Nare , Badikyan Maria , Gregory Mark , Oganesyan Tigran , Muradyan Satenik , Petrosyan Razmik , Ghahramanyan Nerses , Ehrenpreis Eli D. , Hakobyan Yervand 
Published: September 2024

Introduction. An estimated 40% of patients undergoing systemic chemotherapy develop oral mucositis (OM), a major cause of morbidity in cancer patients. These are only a few options for preventing and treating OM, and these do not include FDA-registered devices. Bocaliner™ is an FDA-registered Class I medical device, designed to enhance the effects of oral topical therapies by prolonging the retention of local agents. This study examines the tolerability of the device in a group of patients with hematologic malignancies undergoing systemic chemotherapy.
Methods. An initial interim analysis of data from Phase 1/Phase 2 randomized, controlled trial SPOM (Study for the Prevention of Oral Mucositis, NCT05338398) was performed. Patients with blood malignancies undergoing chemotherapy at the Yeolyan Hematology and Oncology Center (Yerevan, Armenia) were randomized into two groups after initiation of chemotherapy: benzydamine (0.15%,120mL) or saline (0.9%, 120mL) mouthwash both applied multiple times daily for 14 days after the start of the systemic treatment. Half of the patients in each study group were randomly assigned to a Bocaliner device with instructions for use immediately following each mouthwash use. Patients completed questionnaires regarding the tolerability and safety of the device on days 1 and day 14 of chemotherapy and use of the device.
Results. At the time of the interim analysis, 28 patients who received oral devices had completed the study. The mean age of participants was 49 years and 14 (50%) were female. The median number of times of medical device daily use was 3, and the median duration of each use was 10 minutes. On the initial tryout of the device, 22 (71%) of patients reported tolerating it well, and 6 (29%) reported it caused some discomfort. After 14 days of use, 15 patients (35.7%) reported benefit from the device, with 6 (21.4%) of patients stating the device helped to reduce pain, 4 (14.3%) indicating that it helped them to eat, and 5 (17.8%) patients claiming both benefits. Adverse events after 14 days of use included discomfort (n=2, 7.1%), pain around the cheekbone (n=3, 10.7%), nausea (n=2, 7.1%), and increased salivation (n=1, 3.6%); none of these led to discontinuation of using the device. Eighteen (64%) participants said they would use the device again. Five patients (17.8%) developed OM during chemotherapy.
Conclusions. The use of a new medical device designed to enhance oral topical medications in combination with oral topical therapy is well tolerated among patients with hematologic malignancies undergoing systemic chemotherapy. Future studies are planned to evaluate its efficacy for enhancing the prevention and/or treatment of OM with oral topical therapies.
ClinicalTrials.gov ID NCT05338398, filed 2022-4-15