A novel chitosan-based doxepin nano-formulation for chemotherapy-induced oral mucositis: a randomized, double-blinded, placebo-controlled clinical trial

ObjectivesConsidering the prevalence of oral mucositis, we aimed to use the analgesic effects of doxepin with chitosan's antimicrobial and bio-adhesive nature to fabricate a nano-formulation for treating chemotherapy-induced oral mucositis.Materials and methodsNanogel was fabricated via ionic gelation and characterized. Sixty patients were randomly divided and received four different treatments for 14 days: diphenhydramine + aluminum-magnesium mouthwash (control), doxepin mouthwash (DOX MW), chitosan nanogel (CN), and doxepin/chitosan nanogel (CN + DOX). Lesions were assessed with four indices, National Cancer Institute (NCI), World Health Organization (WHO), World Conference on Clinical and Research in Nursing (WCCNR) and visual analog scale (VAS) before and 3, 7, and 14 days after interventions. Kruskal-Wallis test was used for pairwise comparison.ResultsCN had semisolid consistency, uniform spherical shape, an average size of 47.93 & PLUSMN; 21.69 nm, and a zeta potential of + 1.02 & PLUSMN; 0.16 mV. CN + DOX reduced WHO, WCCNR, and VAS scores significantly more than the control three days after the intervention. Seven days after the intervention, CN + DOX reduced NCI and WCCNR considerably more than the control; it reduced WCCNR significantly more than CN. Fourteen days after the intervention, CN + DOX decreased NCI markedly more than the control.ConclusionChitosan-based doxepin nano-formulation might be a promising alternative for routine treatments of oral mucositis.