A randomized, open-label, multicenter, blank-controlled, phase IV clinical trial of Biyan Qingdu Granula in attenuating acute nose and oral damage in patients undergoing radiotherapy for nasopharyngeal carcinoma.

Abstract

6014 Background: This randomized, open-label, multicenter, blank-controlled, phase IV trial aimed to evaluate the efficacy and safety of Biyan Qingdu Granula (BQG) in attenuating acute radiation-induced nasal and oral injuries in nasopharyngeal carcinoma(NPC) patients receiving radiotherapy, and to explore the potential advantages and application values of BQG through comparison with conventional treatments. Methods: This trial was conducted at 30 hospitals in China between July 21st, 2022 and May 21st, 2024.This trial was registered with the Chinese Clinical Trial Registry, ChiCTR2200060900. A total of 1000 NPC patients with first-time radiotherapy or chemoradiotherapy for NPC were randomly assigned (1:3) to receive routine cure (the control group, n=250) or that with additional BQG (the treatment group, n=750). All patients received basic oral hygiene guidance, gargled the oral cavity with normal saline and flushed the nasal cavity with normal saline. The treatment group patients were instructed to take BQG twice daily from the initiation to the end of radiotherapy for 6 weeks. The primary end points were the incidence of nasopharyngeal secretion and the incidence of Oral Mucositis (OM). The second end points were the grade of nasal mucosal congestion, the Visual Analog Scale (VAS) score for sore throat pharyngeal pain, the grade of symptom in dry and burning throat, the incidence of nasal comorbidities, and the incidence of adverse events (AEs). Results: 731 patients in the treatment group and 250 patients in the control group completed the trial, baseline patient characteristics were similar. After six weeks, the incidence of severe nasopharyngeal secretion (grade middle or higher)in the treatment group was significantly lower as compared with the control group(12.4% vs 20.0%, P=0.0033). The incidence of severe OM (World Health Organization grade 3 or higher) was significantly lower in the treatment group than in the control group (12.3% vs 22.4%, P=0.0001). The intergroup rate difference and 95% CI of the incidence of OM between the two groups was -10.1% (-15.8%, -4.4%). The upper limit of the 95% CI was greater than -10%, so it could not be concluded that the experimental group was superior to the control group. However, compared with the control group, the treatment group showed a certain trend in reducing oral mucositis. The BQG group also remarkably reduced the incidence of severe VAS score for sore throat pharyngeal pain and the grade of symptom with dry and burning throat compared to the control group. The incidence of AEs were similar between the groups. Conclusions: BQG significantly attenuated the incidence of nasal secretions in NPC patients undergoing radiotherapy, improved pharyngeal pain and the symptoms with dryness and burning, with a good safety profile. Clinical trial information: ChiCTR2200060900 .