NCT01885065已完成不适用
Efficacy Study of Novel Edible Gel-based Artificial Saliva in Xerostomic Cancer Patients
Dental Innovation Foundation Under Royal Patronage2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Changes in subjective dry mouth score
研究概览
简要总结
The purpose of this study is to determine whether continuous use of edible, gel-based artificial saliva in cancer patients with dry mouth problems will reduce signs and symptoms of dry mouth and improve quality of patients' saliva.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cancer patients who receive/ had received radiotherapy and/or chemotherapy and have dry mouth problems
排除标准
- •mucositis more than grade 1
- •cannot perform oral intake of gel-based artificial saliva eg. aspirate
研究组 & 干预措施
Gel-based artificial saliva
Experimental
Continuous oral intake of edible gel-based artificial saliva (30-50 ml/day) for four weeks
干预措施: Gel-based artificial saliva (Other)
结局指标
主要结局
Changes in subjective dry mouth score
时间窗: baseline, 2 weeks and 4 weeks after intervention
The outcome measure (subjective dry mouth score) will be measured before and 2 and 4 weeks after continuous usage of edible gel-based artificial saliva (30-50 ml/day for at least 5 days per week)
次要结局
- Changes in objective dry mouth score(Baseline, 2 week and 4 weeks after the start date)
- Changes in salivary buffering capacity(Baseline, 2 weeks and 4 weeks after the start date)
- Changes in salivary pH(Baseline, 2 weeks and 4 weeks after the start date)
研究者
研究点 (2)
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