Effects of a bioadhesive barrier-forming oral liquid on pain due to radiation-induced oral mucositis in patients with head and neck cancer: A randomized crossover, preliminary study

Abstract

Background/purpose Bioadhesive barrier-forming oral liquid, is a recently developed medical material for the management of pain caused by oral mucositis associated with cancer radiotherapy or chemotherapy. The purpose of this study was to evaluate the effectiveness of this liquid in relieving pain resulting from radiation-induced oral mucositis in patients with head and neck cancer. Materials and methods This randomized, crossover trial investigated the analgesic effects of bioadhesive barrier-forming oral liquid using dexamethasone ointment as a control. Fifteen patients with mild or moderate pain due to radiation-induced oral mucositis were randomly assigned to two groups. Group A applied dexamethasone ointment once on day 1, had a wash-out period on day 2, and used bioadhesive barrier-forming oral liquid once on day 3. Conversely, group B used bioadhesive barrier-forming oral liquid on day 1, had a wash-out period on day 2, and applied dexamethasone ointment once on day 3. The effectiveness in relieving pain was compared between the two groups. Results One patient reported nausea immediately after the application of bioadhesive barrier-forming oral liquid and was therefore excluded from the analysis. Dexamethasone ointment and bioadhesive barrier-forming oral liquid relieved pain in 85.7% and 71.4% patients, respectively (p = 0.682). Nine patients wished to continue dexamethasone ointment after the study, while only five wished to continue bioadhesive barrier-forming oral liquid. Conclusion Our findings suggest that the analgesic effect of bioadhesive barrier-forming oral liquid is comparable or inferior to that of dexamethasone ointment in patients with radiation-induced oral mucositis. Further studies are needed to verify these findings.

Manejo odontológico de las manifestaciones orales inducidas por radioterapia de cabeza y cuello

“…Pueden utilizarse agentes tópicos o sistémicos, los cuales están disponibles en diversas presentaciones. Un estudio realizado en pacientes con RIOM comparó el efecto de un líquido oral (Episil), formador de barrera cristalina bioadhesiva superficial que protege a la mucosa, con la pomada de dexametasona para mitigar el dolor relacionado a la mucositis oral y encontró que el Episil alivió el dolor en un 71,4% y la pomada de dexametasona en un 85,7% de los pacientes 30 . Rasic et al 31 administraron localmente un spray compuesto por lisozima, cetilpiridinio y lidocaína en pacientes con RIOM y encontraron que fue eficaz al disminuir los signos de inflamación y la intensidad del dolor al comer y hablar.…”

Clinical investigation of use of Episil® oral solution in oral mucositis during radiotherapy for head and neck cancer

“…Ueno T et al used Episil® in ten Japanese cancer patients and clearly demonstrated its pain-relieving effect on OM [ 12 ], however, only one RT with HNC patient was included, the effects of Episil® in patients with HNC, remain unclear. Moreover, adverse reactions to Episil® have been observed, including nausea and difficulties experienced in the proper application at the OM site [ 13 ]. Clinically, we have observed both benefits and difficulties when using Episil® in patients with HNC; however, these experiences have been rarely discussed in the literature and thus, more evidence is needed to support the use of Episil® in patients with HNC.…”

Clinical Investigation Of Use Of Episil® Oral Solution In Oral Mucositis During Radiotherapy For Head And Neck Cancer

“…A previous study reported that Episil® is an effective and safe product for pain relief caused by OM in patients with cancer [8,12]. However, adverse reactions of Episil® have been noted, including nausea and di culties in proper application at the OM site [13].…”