The Effect of Curcuma Long Oral Gel in Relation to Salivary Epidermal Growth Factor & Interleukin-8 on Radiation Induced Oral Mucositis in Iraqi Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Onset of radiation induced mucositis
研究概览
简要总结
The goal of this clinical study is to investigate the effect of a curcuma longa oral gel (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and provide a context for understanding if there is a relationship between the curcumin clinical effect and production of EGFs and IL8.
Researchers will compare between curcumin group and standard treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 16 years having histopathologically confirmed cancer in head and neck region who planned to have radiation with head and neck mask.
- •Scheduled for 6-8 weeks of radiotherapy with 60-70Gy radiation (200cgy/fraction for 5 days/week).
排除标准
- •patient with hodgkin lymphoma.
- •Any allergy to curcumin or other condiments.
研究组 & 干预措施
Standard treatment group
干预措施: Standard Preparation (Drug)
Curcuma longa oral gel group
干预措施: Curcumin Gel (Drug)
结局指标
主要结局
Onset of radiation induced mucositis
时间窗: Assessment every week starting from first visit until the onset of mucositis (up to 2 months)
Onset (at which week) of radiation induced mucositis in relation to EGF and IL8
Change in severity of radiation induced mucositis
时间窗: Assessment every week starting from first visit of radiation unit it completion (average of 2 months)
Change in severity (degree of illness) of radiation induced mucositis in relation to EGF \& IL-8 by World Health Organization (WHO) mucositis scale {0: no. 1: mild. 2 and 3 : moderate. 4: severe}
次要结局
未报告次要终点
研究者
sarah adnan abdul-jabbar
principal investigator
University of Baghdad