Boesenbergia rotunda extract-based mucoadhesive mouth gargle for chemoradiation-induced oral mucositis: A prospective randomized controlled study

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.

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.