The Effects of Hyaluronic Acid Gel on Oral Mucositis in Children Receiving Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VAS pain score
研究概览
简要总结
Oral mucositis (OM) is a common side effect of systemic chemotherapy (CT) in cancer patients. The aim of this study was to investigate the effect of hyaluronic acid (HA) gel on OM in children receiving CT.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children who receive chemotherapy
- •hospitalized patient
排除标准
- •Allergy about using drugs
研究组 & 干预措施
hyaluronic acid
The hyaluronic acid is a natural polysaccharide composed of D-glucuronic acid and N-acetyl-D-glucosamine and is synthesized as a linear polymer. The majority of the cells have a capacity to synthesize HA at a varying extent in the cell cycle.
干预措施: Hyaluronic acid (Drug)
sodium bicarbonate
干预措施: Sodium bicarbonate (Drug)
结局指标
主要结局
VAS pain score
时间窗: Day 11th
A Visual Analogue Scale (VAS) is one of the pain rating scales between 1-10.
World Health Organization Common Toxicity Criteria Scale
时间窗: day 11th
The lesions were classified as Grade 0 = absent; Grade 1 = pain and erythema; Grade 2 = erythema and ulcers with no difficulty in swallowing solid food; Grade 3 = ulcers requiring only liquid diet; and Grade 4 = requiring parenteral and enteral nutrition support.
次要结局
未报告次要终点
研究者
Serap Keskin Tunc
associate professor
Yuzuncu Yıl University