A barrier-forming gel for oral mucositis in head and neck cancers patients undergoing radiotherapy: randomized, controlled, multicenter trial.

Abstract

Episil is a type of barrier-forming gel. This study was to observe the effects of Episil on oral mucositis (OM) and nutritional status in patients with head and neck cancer (HNC) receiving radiotherapy. A multicenter and randomized controlled trial included 200 intention-to-treat patients across 7 medical centers in China from February 2022 to June 2024. HNC patients eligible for enrollment were randomly divided into control group and Episil group by 1:1. When the patients developed OM, the control group was gargled with oral gargle solution and the Episil group were sprayed with Episil after using the same gargle intervention. The primary endpoint was incidence of advanced OM, and secondary endpoints were pain relief, nutritional status, overall survival (OS), progression-free survival (PFS), immune function, quality of life (QOL), psychology status and other adverse effects. This trial was registered with Chinese Clinical Trials Registry (URL: https://www.chictr.org.cn/bin/project/edit?pid=136241); accession no: ChiCTR2100055088. A total of 200 patients were enrolled from 2022 to 2024, including 100 in the control group and 100 in the Episil group. The incidence of Grade III/IV OM in the Episil group was lower than that in the control group (4/100, 4% vs. 14/100, 14%, <i>P</i> = 0.024). The intensity decline of oral pain at 2 h (<i>P</i> < 0.0001) and 4 h (<i>P</i> < 0.0001) after first drug therapy of Episil group was better than control group. After 4 weeks of radiotherapy (Week 4), the weight loss, the loss of body mass index (BMI) and the loss of pre-albumin in the Episil group were lower than those in the control group (<i>P</i> = 0.036, <i>P</i> = 0.040, <i>P</i> = 0.0040). The EORTC QLQ-C30 global health status score of QOL at Week 4 was better in the Episil group than in the control group (65.00 (5.17) vs. 60.02 (5.38), <i>P</i> < 0.0001). No significant difference in the incidence of other adverse reactions was detected between the control group and Episil group (all <i>P</i> > 0.05). Episil was shown to delay advanced OM and oral pain in HNC patients undergoing radiotherapy, while improving nutritional status and QOL. Larger prospective multi-national studies are required for further investigation. This study was funded by the Jilin Province Health Science And Technology ability improvement program (grant numbers: 2024A021), The First Hospital of Jilin University Talent Reserve Program (grant numbers: JDYY-TRP-2024012) and Jilin Province Medical and Health Talents Special Foundation (grant numbers: JLSWSRCZX2023-68 and JLSRCZX2025-042).