Abstract
Background
Chemotherapy-associated oral mucositis (OM) is a prevalent and debilitating complication in patients undergoing cancer treatment, lacking effective preventive and therapeutic options. Boesenbergia rotunda (BR), a traditional medicinal plant, exhibits potent anti-inflammatory and antimicrobial activities. The objective of this study was to evaluate a BR extract-based mouth gargle for the management of concurrent chemoradiotherapy (CCRT)-induced OM.Methods
BR extract was evaluated for cytotoxicity and anti-inflammatory activity. The mucoadhesive mouth gargle was characterized by antimicrobial activity, salivary release, and mucosal deposition. Clinical evaluation was performed in patients with head and neck cancer receiving CCRT in a prospective randomized controlled trial conducted between September 2024 and November 2025. The primary outcome of the clinical phase was to compare the incidence of OM at 6 weeks.Results
BR extract was non-cytotoxic at concentrations below 1 µg/mL and significantly suppressed nitric oxide production in lipopolysaccharide-stimulated RAW 264.7 cells. The formulation demonstrated antimicrobial activity, rapid release within 2 min, and effective mucosal deposition. Fifty-six patients were enrolled, with 73.98% adherence. The incidence of overall OM was significantly lower in the BR extract group than in the control group (30.4% vs. 41.1%, p = 0.04). Lip swelling at week 3 occurred less frequently in the BR group than in the non-intervention group (1.8% vs. 14.3%, p = 0.03), while other adverse events were comparable between groups.Conclusion
The BR extract-based mucoadhesive mouth gargle is biocompatible, exhibits anti-inflammatory and antimicrobial activities, and achieves effective mucosal delivery. These findings indicate its potential as a therapeutic strategy for managing CCRT-induced OM.Clinical trial number
Not applicable.