A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from baseline in Xerostomia grades
研究概览
简要总结
The purpose of this study is to determine whether the use of pure honey will help in the treatment of radiation induced xerostomia and oral mucositis (symptom management)
详细描述
Radiation-induced mucositis is a normal acute side effect of radiotherapy treatment. Exposure of ionising radiation to oral, pharyngeal and laryngeal mucosa gives rise to radiation epithelitis towards the second and third weeks of conventional fractionated radiotherapy. Likewise, salivary flow may decrease by approximately 50% during the first week of radiotherapy and upwards of 80% by the seventh week of treatment. Acute radiation-induced xerostomia is associated with inflammatory reaction. The study will include an intervention and a control group, one receiving honey prior and after the radiotherapy and the other group not receiving honey at all.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive radiotherapy (RT) to the oral cavity will be included in the study.
- •Patients with a confirmed histologic diagnosis of head and neck cancer referred to non-palliative radiotherapy will enter into this trial.
- •aged over 18
- •receiving radiotherapy for at least four weeks
排除标准
- •Allergic to honey
- •confirmed and medically treated diabetes mellitus
研究组 & 干预措施
Saline mouthwash
The patients in this group will receive saline rinses
干预措施: Normal Saline (Other)
receiving Honey
The patients will receive honey mouthwash rinses
干预措施: Honey mouthwash (Dietary Supplement)
结局指标
主要结局
Change from baseline in Xerostomia grades
时间窗: 1 week, 2 weeks, 3 weeks, 4 weeks
Change from baseline in oral mucositis grades
时间窗: 1 week, 2 weeks, 3 weeks, 4 weeks
次要结局
- Changes in the General satisfaction of comfort(1 week, 2 week, 3 week, 4 week)
- Change in baseline weight in one month(4 weeks)
研究者
Dr. Andreas Charalambous
Lecturer-Researcher
Cyprus University of Technology