Effects of Topical Dexpanthenol on Chemotherapy and Radiotherapy Induced Oral Mucositis
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- reduction of intensity of mucositis
研究概览
简要总结
Oral mucositis can be a significant problem for cancer patients. It is typically associated with pain and increased risk of infection and can lead to impaired nutritional status and inadequate hydration.it can be seen in the patient population receiving high-dose head and neck radiation therapy (85%-100%). Topical dexpanthenol acts like a moisturizer, improving stratum corneum hydration, reducing transepidermal water loss and maintaining skin softness and elasticity. The stimulation of epithelization, granulation and mitigation of itching were the most prominent effects of formulations containing dexpanthenol. The investigators suppose that dexpanthenol mouth wash may improve oral mucositis.
详细描述
Patients will be given a bottle of 5% Dexpanthenol mouthwash and they are asked to rinse 10 ml of it three times a day. At the onset of mucositis and then for 4 subsequent weeks they will be examined to evaluate the condition of their oral mucosa.By the advent of mucositis stage 4 ,at any time during the 4 weeks of study,the patient would be out.if any patient shows allergic reaction to dexpanthenol,he/she would be out of study too.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •without any systemic disease
- •estimated survival of at least 6 months
- •without any mental disorders
- •grade 1 to 3 WHO mucositis
排除标准
- •development of grade 4 WHO mucositis
- •Brachytherapy
- •allergy to the drug
- •dissatisfaction of the patient
研究组 & 干预措施
normal saline
mouth wash of normal saline ,three times a day, 10 cc each time
干预措施: Dexpanthenol (Drug)
结局指标
主要结局
reduction of intensity of mucositis
时间窗: first week (week one)
measuring of the intensity of mucositis by visual examination and asking the patient about pain and discomfort
次要结局
未报告次要终点