The Effect of 0.15% Benzydamine Hydrochloride (Difflam) Oral Spray on the Severity of Radiation-induced Oral Mucositis in Patients Receiving High-Dose Radiotherapy: An Open-Label Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Weekly severity of oral mucositis
研究概览
简要总结
This single-center, open-label, randomized clinical trial evaluates the effect of 0.15% benzydamine hydrochloride (Difflam) oral spray on the severity of radiation-induced oral mucositis in patients with head and neck cancer receiving high-dose radiotherapy (≥50 Gy) without concurrent chemotherapy. Oral mucositis is a common and clinically significant complication of radiotherapy that can cause pain, difficulty swallowing, nutritional impairment, and treatment interruption.
Participants are randomly assigned to receive either standard oral care alone or standard oral care plus benzydamine oral spray for 6 weeks. Oral mucositis severity is assessed weekly using the World Health Organization (WHO) oral mucositis grading scale. The study aims to determine whether benzydamine reduces the progression and severity of oral mucositis in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 years or older
- •Pathologically confirmed head and neck cancer
- •Currently undergoing RT
- •Cumulative total radiation dose exceeding 50 Gy
- •Patients were enrolled in the study after their diagnosis of OM was confirmed by a specialist, which occurred approximately two weeks after the initiation of radiotherapy
- •All subjects had grade 1 OM according to the WHO criteria at baseline, except for two patients in the intervention group who presented with grade 2 severity at the start of the study
- •None of participants received concurrent chemotherapy during the study period
排除标准
- •Use of concurrent treatments affecting OM
- •Incomplete follow-up
- •Other conditions influencing its progression
- •patient withdrawal
研究组 & 干预措施
Benzydamine plus standard oral care
participants in this arm received standard oral care, including routine oral hygiene measures and saline mouth rinses, in addition to 0.15% benzydamine hydrochloride oral spray for 6 weeks.
干预措施: benzydamine hydrochloride (Drug)
Benzydamine plus standard oral care
participants in this arm received standard oral care, including routine oral hygiene measures and saline mouth rinses, in addition to 0.15% benzydamine hydrochloride oral spray for 6 weeks.
干预措施: saline mouth rinse (Other)
Standard oral care alone
participants in this arm received standard oral care alone, including routine oral hygiene measures and saline mouth rinses, without benzydamine oral spray.
干预措施: saline mouth rinse (Other)
结局指标
主要结局
Weekly severity of oral mucositis
时间窗: Weekly for 6 weeks
Oral mucositis severity was assessed weekly for 6 weeks by a specialist using the World Health Organization (WHO) oral mucositis grading scale. The scale ranges from 0 to 4, where 0 indicates no mucositis and 4 indicates sever mucositis. Higher represent worse severity.
次要结局
- Proportion of patients who developed grade 3 oral mucositis(During the 6-week follow-up period)
- Between-group difference in oral mucositis severity at weeks 4 and 6(Week 4 and week 6)