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

Objective: To evaluate the efficacy of NAHAO® oral mucosal antibacterial care solution (NAHAO® 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®. The expression of NF-κB 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® 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® spray was involved in inflammation inhibition via NF-κB pathway. The results of clinical study showed that NAHAO® 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® spray alleviates pain and improves the diet situation in OM patients, which is partly mediated through the inhibition of NF-κB pathway.