NCT00901732Unknown1 期
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol.
研究概览
简要总结
Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed Head and Neck Cancer patients with planned Radiation therapy
- •Have at least one of 10 pre-defined anatomic mucosal subsites on view
- •Age >/= 18 years
- •Life expectancy >/= 6 months
- •Planned RT to the head/neck
- •Must be able to perform oral rinse
排除标准
- •Active infections of oral cavity
- •physiologic condition that precludes the use of an oral rinse
- •Hypersensitivity to Caphosol ingredients
- •Presence of mucosal ulceration at baseline
- •Poorly controlled hypertension, DM or other serious medical/psychiatric illness
结局指标
主要结局
The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol.
时间窗: 15 weeks
次要结局
- The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake)(15 weeks)
研究者
研究点 (12)
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