Efficacy and safety of Sapylin versus dexamethasone atomized inhalation for CCRT-induced oral mucositis in patients with nasopharyngeal carcinoma: A randomized, parallel design, and non-inferiority clinical trial.

Abstract

6075 Background: Radiation-induced oral mucositis (RIOM) is a common adverse reaction to radiotherapy and chemotherapy in patients with nasopharyngeal carcinoma (NPC). Sapylin is an immune adjuvant with anti-tumor effects in multiple malignancies. This study investigated the efficacy and safety of Sapylin versus dexamethasone for treating RIOM in patients with NPC. Methods: This prospective, parallel-design, non-inferiority randomized study aims to investigate the effects of inhaling atomized Sapylin versus dexamethasone on the incidence and severity of RIOM in patients with NPC undergoing concurrent chemoradiotherapy (CCRT). A total of 100 patients were enrolled and randomized in a 1:1 ratio into the intervention (Sapylin) and control (dexamethasone) groups. Both groups received cisplatin-based CCRT. The Sapylin and dexamethasone groups received Sapylin (1 KE) and dexamethasone (10 mg), respectively, both via atomized inhalation once daily. Both treatments commenced on the first day of CCRT and continue until the conclusion of radiotherapy. Results: Comparisons among groups showed no statistically significant differences in patient characteristics after randomization of patients. Compared to the dexamethasone group, the Sapylin group demonstrated a lower incidence of RIOM (78.9% vs. 83.6%, P < 0.05) and a significantly reduced incidence of severe RIOM (grades III-IV) (37.1% vs. 42.5%, P < 0.05). The onset times for grades I, II, III, and IV RIOM in the Sapylin group were later than those observed in the dexamethasone group (P < 0.05). From baseline to the conclusion of radiotherapy (RT), the changes in Body Mass Index (BMI) in both groups were statistically significant (P < 0.001). During RT, the decrease in BMI was less pronounced in the Sapylin group, with a mean change of 0.97 ± 0.76 (mean ± SD), compared to a larger decrease in the dexamethasone group, which had a mean reduction of 2.02 ± 0.81 (mean ± SD). A significant positive correlation was found between changes in BMI and the severity of RIOM (r = 0.671, p < 0.003). No significant difference in the incidence of adverse reactions was observed between the two groups (P > 0.05). Conclusions: Compared to dexamethasone group, Sapylin group resulted in a decrease in the incidence and severity of RIOM in patients with NPC without obvious side effects. The use of Sapylin atomized inhalation regimen is both safe and effective, and it positively influences the improvement of nutritional status. Clinical trial information: ChiCTR2200064576.