Propolis for Management of Chemotherapy-Induced Oral Mucositis in Pediatric Patients: A Randomized Controlled Clinical Trial With Biochemical Analysis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- oral mucositis score (WHO)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of propolis in the prevention of oral mucositis and reducing pain score in children undergoing chemotherapy, and assessing its impact on body mass index, pediatric quality of life and total antioxidant assay. The main question it aims to answer is:
What is the effect of propolis on oral mucositis scores in children undergoing chemotherapy?
Participants will:
Take propolis 3 times daily for 21 days follow up weekly for 3 weeks
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of both genders less than 18 years receiving intensive chemotherapy.
- •Oncology patients receiving intensified chemotherapy at Oncology unit, Children's Hospital, Ain Shams University, Egypt, who meet the following criteria:
- •Taking intensified chemotherapy
- •A healthy oral mucosa.
排除标准
- •Allergy to bee products.
- •Severe systemic illness unrelated to cancer (Diabetes, Hypertension, ...)
- •Inability to take oral medication or unwillingness to participate in the study
- •Radiotherapy in the head and neck area.
- •Malignant or potentially malignant lesions of the oral cavity.
- •Undergoing any other procedures to prevent oral mucositis except standard oral care.
- •Patients are unable to commit to the study.
研究组 & 干预措施
control group
Standard oral care (chlorohexidine mouth wash and topical anti-fungal) three times daily for 21 days
干预措施: chlorohexidine mouthwash and topical antifungal (Drug)
study group
propolis medicated jelly candy+ standard oral care (chlorohexidine and topical anti-fungal) three times daily for 21 days
干预措施: propolis (Drug)
study group
propolis medicated jelly candy+ standard oral care (chlorohexidine and topical anti-fungal) three times daily for 21 days
干预措施: chlorohexidine mouthwash and topical antifungal (Drug)
结局指标
主要结局
oral mucositis score (WHO)
时间窗: 3 weeks
Assess the effectiveness of propolis in treatment of chemotherapy induced oral mucositis in pediatric cancer patients using the WHO Scale (WHO), scoring from 0 to 4.
次要结局
- pain (VAS)(3 weeks)
- body mass index(3 weeks)
- Pediatric Quality of Life(3 weeks)
- Total anti-oxidant assay(3 weeks)
研究者
Dina Borham Abdelhafez Abdellatif Elkhouly
Assistant Lecturer
Ain Shams University