Ulinastatin in the treatment of radiotherapy-induced oral mucositis in locoregionally advanced nasopharyngeal carcinoma: a phase 3 randomized clinical trial.

ABSTRACT: Radiotherapy-induced oral mucositis (RTOM) is a common side effect of radiotherapy in locoregionally advanced nasopharyngeal carcinoma (LA-NPC) receiving concurrent chemoradiotherapy (CCRT). In this phase 3 trial, we aim to evaluate the efficacy and safety of Ulinastatin (UTI) for the prevention and treatment of RTOM in LA-NPC patients (NCT03387774). The primary endpoint is the incidence of grade ≥3 acute RTOM during radiotherapy. Secondary endpoints include cumulative incidence of RTOM, recovery rate, the onset time and duration of grade ≥3 RTOM, oral pain (severe), safety and survival outcomes. 179 eligible patients are randomly assigned to UTI Group (n = 89) or Control group (n = 90). All UTI group patients complete UTI treatment as planned, and both groups complete scheduled CCRT. The

SUBMITTER: Wang X 

PROVIDER: S-EPMC11930952 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature