Phase I Assessing the Preventing and Therapeutic Effect of Propolis in Radiotherapy Induced Mucositis of Head and Neck Cancers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- NCI.CTC Scale
研究概览
简要总结
The purpose of this study is to determine whether propolis is effective in the treatment and prevention of radiotherapy induced oral mucositis.
详细描述
Patients with head and neck malignancy with inclusion criteria randomly divide in 2 groups and take the intervention.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •need of radiotherapy
- •at least half of the mouth in the field of radiation
- •dose 50 -70 Gy
- •head & neck malignancy
排除标准
- •systemic disease
- •FBS > 150 WBC > 3000
- •history of radiotherapy
- •need of chemotherapy
- •systemic disease
研究组 & 干预措施
placebo mouth wash
10 patients swish & swallow 15 ml placebo mouth wash for at least 5 min from the first session of radiotherapy until the last session
干预措施: propolis (Drug)
propolis
10 patients swish & swallow 15 ml propolis mouth wash for at least 5 min from the first session of radiotherapy until the last session
干预措施: propolis (Drug)
结局指标
主要结局
NCI.CTC Scale
时间窗: 9 month
we use NCI-CTC scale for patients in 2 groups to assess effect of propolis mouth wash on prevention and treatment of mucositis in patients under radiotherapy.We measured signs(size and sypmtoms) of mucositis by NCI-CTC scale and also we assessed the onset of the mucositis to describe the prevention efficacy of propolis.
次要结局
- hyposalivation scale(9 month)
研究者
ATESSA PAKFETRAT
Associate professor
Mashhad University of Medical Sciences