Tolerability and safety of a new oral device for prevention and treatment of oral mucositis in patients with hematologic malignancies undergoing chemotherapy
Mené sur 28 patients atteints d'un cancer hématologique traité par chimiothérapie, cet essai randomisé de phase I/II évalue la tolérabilité d'un nouveau dispositif oral pour prévenir et traiter une mucite buccale
Purpose: Around 40% of patients undergoing systemic chemotherapy develop oral mucositis (OM), a major cause of morbidity in cancer patients. There are only a few options for preventing and treating OM. This study examines the tolerability of a novel oral device (Bocaliner™), designed to enhance the effects of oral topical therapies, in patients with hematologic malignancies receiving chemotherapy.
Methods: Data from phase 1/phase 2 randomized controlled trial SPOM (Study for the Prevention of Oral Mucositis) was analyzed. Patients from the Yeolyan Hematology and Oncology Center (Yerevan, Armenia) were randomized into two groups: benzydamine or saline mouthwash. Half of the patients in each study group were randomly assigned to Bocaliner™. Tolerability and safety questionnaires on days 1 and 14 of chemotherapy were completed.
Results: Twenty-eight patients (mean age of 49 years; 50% female) received oral devices and completed the study. On the tryout of the device, 22 (78.6%) patients reported tolerating it well, and six (21.4%) reported some discomfort. After 14 days, 15 patients (35.7%) reported benefit from the use, with six (21.4%) of patients stating the device helped to reduce pain, four (14.3%) indicating that it helped them to eat, and five (17.8%) claiming both. Adverse events 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 the use. Eighteen (64%) participants said they would use the device again. OM developed in five patients (17.8%).
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 on chemotherapy.
Supportive Care in Cancer , résumé, 2025