Effects of an oral mucosa protective formulation on chemotherapy- and/ or radiotherapy-induced oral mucositis: A prospective study

Oral mucositis (OM) associated with cancer treatment not only impairs patients’ quality of life but also causes treatment delays or changes. This prospective exploratory study was conducted to evaluate the efficacy of Episil® oral liquid, which is an approved protective formulation for the oral mucosa in patients with OM. The extent of the pain-relieving efect, feeling during use, and adverse events or problems were evaluated.
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Effects of an oral mucosa protective formulation on chemotherapy- and/ or radiotherapy-induced oral mucositis: A prospective studyUenoetal. BMC Cancer (2022) 22:90https://doi.org/10.1186/s12885-021-09107-6 RESEARCH Open AccessEffects ofanoral mucosa protectiveformulation onchemotherapy‑ and/orradiotherapy‑induced oral mucositis:aprospective studyTakaoUeno1*, WakakoYatsuoka1, HirotoIshiki2, KanakoMiyano3and YasuhitoUezono3,4,5  Abstract  Background:  Oral mucositis (OM) associated with cancer treatment not only impairs patients’ quality of life but also Episil® oral liquid, which is an approved protective formulation for the oral mucosa in patients with OM. The extent of causes treatment delays or changes. This prospective exploratory study was conducted to evaluate the efficacy of the pain-relieving effect, feeling during use, and adverse events or problems were evaluated. Methods:  In total, 10 Japanese cancer patients with OM receiving chemotherapy, pretreatment therapy for hemat- opoietic stem cell transplantation, or radiation therapy for head and neck cancer were enrolled. mean NRS began to decrease at 5min after using Episil® (7.1 ± 1.4 to 4.6 ± 2.87; p = 0.264). A significant decrease was Results:  A numerical rating scale (NRS) was used to assess oral pain intensity due to OM. Compared to baseline, the observed in the pain score after using Episil® compared with that before using Episil®, and this effect lasted up to 120min. The protective effects of Episil® were observed 3–5min after application. Some patients felt slight soreness or discomfort when applying Episil®. However, this discomfort due to Episil®’s stimulation was within the allowable range and transient. No adverse events were observed in any of the cases. Conclusions:  The results of this prospective study showed that Episil® could be an effective treatment to relieve oral pain in Japanese patients with moderate to severe OM, and this newly approved product might adequately support patients’ oral intake. Trial registration:  University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR)  (UMIN0​00031​921). Keywords:  Bioadhesive, Breakthrough pain, Deglutition, Hydrogel, Mucositis, Opioid analgesicsBackground transplantation, or in patients with head and neck malig-Oral mucositis (OM) is a debilitating side effect fre- nancies undergoing radiation therapy [1, 2]. OM can bequently observed in patients undergoing high-dose highly problematic during treatment as it is extremelychemotherapy, pretreatment therapy for stem cell painful, causes oral intake reduction due to that oral pain, and can be a route of systemic infections [3–5]. Since OM can lead to malnutrition, dehydration, and infec-*Correspondence: taueno@ncc.go.jp tion, it can even cause treatment delay or interruption.1 Department ofDentistry, National Cancer Center Hospital, 5‑1‑1 Tsukiji,Chuo‑ku, Tokyo104‑0045, Japan In addition, previous reports have shown that OM canFull list of author information is available at the end of the article be a dose-limiting toxicity [5, 6]. Therefore, OM not only © The Author(s) 2021. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this ...