Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2026
Boesenbergia rotunda extract-based mucoadhesive mouth gargle for chemoradiation-induced oral mucositis: A prospective randomized controlled study.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
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Abstract
backgroundChemotherapy-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.
methodsBR 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.
resultsBR 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.
conclusionThe 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.
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