Efficacy and safety of NAHAO(R) hydrogel in amelioration of chemoradiotherapy-induced oral mucositis: An preliminary clinical study (ChiCTR2200064766).

OBJECTIVE: To evaluate the efficacy of NAHAO(R) oral mucosal antibacterial care solution (NAHAO(R) spray) on attenuating oral mucositis (OM) symptoms and related mechanisms investigation. MATERIAL AND METHODS: Experimental OM models were established by acetic acid and 5-fluorouracil combined with mechanical trauma. We investigated spontaneous pain of conscious OM rats after using NAHAO(R). The expression of NF-kappaB in affected trigeminal ganglion was measured by western blot. In clinical study, 60 patients who developed post-treatment OM of grade 2 or above or persistent mucosal pain with a score equal to or greater than 4 points were selected. All patients were required to receive NAHAO(R) spray 8 times a day and were examined for OM degrees and oral mucosal pain scores before and after application. RESULTS: Experimental data from experimental model suggested that clinical efficacy of NAHAO(R) spray was involved in inflammation inhibition via NF-kappaB pathway. The results of clinical study showed that NAHAO(R) spray improved the symptoms of OM, there is statistically significant difference in oral mucosal pain scores after treated with NAHAO, and the dietary restrictions were also improved. CONCLUSION: NAHAO(R) spray alleviates pain and improves the diet situation in OM patients, which is partly mediated through the inhibition of NF-kappaB pathway.