A barrier-forming gel for oral mucositis in head and neck cancers patients undergoing radiotherapy: randomized, controlled, multicenter trial
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background: 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. Methods: 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. Findings: > 0.05). Interpretation: 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. Funding: 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).
Source: EClinicalMedicine
Authors: Jinlong Wei, Qin Zhao, Sitong Chang, Yulei Chen, Jie Wu, Chuncheng Hao, Wenxue Zhang, Xia Li, Haijun Lu, Xiaojing Jia, Bing Wang, Yan Ma, Aifu Wang, Xin Jiang
Institutions: Jilin University, First Hospital of Jilin University, Harbin Medical University, Third Affiliated Hospital of Harbin Medical University, Tianjin Medical University General Hospital, Liaoning Cancer Hospital & Institute, Affiliated Hospital of Qingdao University, Second Affiliated Hospital of Jilin University, Jilin Province Tumor Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $5,780
OpenAlex ID: W7104402425