Comparative efficacy of duo-gargling with sodium bicarbonate solution and Benzydamine hydrochloride (Difflam®) to single gargling with Benzydamine hydrochloride (Difflam®) in head and neck cancer participants who are receiving concurrent chemoradiotherapy
Keywords:
benzydamine, chemoradiotherapy, head and neck cancer, oral mucositis, sodium bicarbonateAbstract
Background: Radiation-induced oral mucositis (RIOM) is a common complication of concurrent chemoradiotherapy (CCRT) in head and neck cancer (HNC). Benzydamine HCl is an established anti-inflammatory rinse for preventing RIOM, but it is not known whether adding sodium bicarbonate, which buffers oral pH and reduces microbial load, provides any added benefit.
Objective: To compare duo-gargling (Benzydamine HCl followed by sodium bicarbonate) with Benzydamine HCl alone for RIOM prevention in HNC patients receiving cisplatin-based CCRT.
Methods: In this preliminary analysis of a single-center, randomized, single-blinded trial, HNC patients receiving curativeintent CCRT were randomized 1:1 to duo-gargling or single gargling four times daily. The primary endpoint was the blindedassessed Oral Mucositis Assessment Scale (OMAS) score at week 7. Secondary endpoints included CTCAE v5.0 grading and supportive-care needs. Mixed-effects models were used for longitudinal analysis.
Results: Twenty-one patients were analyzed (duo-gargling n = 10; single gargling n = 11) with balanced baseline characteristics. Mean week-7 OMAS score did not differ between groups (17.20 ± 4.89 vs. 18.55 ± 7.84; mean difference 1.35, 95% CI −4.19 to 6.88;P = 0.647), and there was no significant difference at any week. Grade ≥3 mucositis at week 7 was lower with duo-gargling (10.0% vs. 36.4%) but not significant. Opioid prescription at week 3 was significantly lower with duo-gargling (0.0% vs. 45.5%;P = 0.035).
Conclusion: In this preliminary analysis, adding sodium bicarbonate to Benzydamine HCl did not significantly reduce OMAS scores compared with Benzydamine HCl alone. Duo-gargling did show fewer severe mucositis events and lower early opioid use, but these findings need to be confirmed in the full study.
