NCT01092975终止1 期
A Phase I Safety Study of Phenylephrine Applied Topically to the Oral Mucosa in Cancer Patients Receiving Radiation to Sub-mandibular Lymph Nodes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.
研究概览
简要总结
The purpose of this study is to determine if applying the drug phenylephrine to the inside of the mouth can be done safely and is tolerable to use in cancer patients receiving radiation to the Sub-mandibular lymph nodes.
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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cancer patients scheduled to receive at least 5 weeks of radiation therapy to the sub-mandibular lymph nodes
- •normal ECG
- •normal blood pressure
排除标准
- •untreated cardiac disease
- •connective tissue disorders
- •open sores, wound, ulcerations to oral cavity
- •allergy to phenylephrine
- •know untreated hypertensin
- •abnormal ECG in past 6 months
- •taking prescription monoamine oxidase inhibitor (MAOI)
- •are pregnant
研究组 & 干预措施
1.25 mg phenylephrine
Experimental
干预措施: phenylephrine solution (Drug)
2.5 mg phenylephrine
Experimental
干预措施: phenylephrine solution (Drug)
5.0 mg phenylephrine
Experimental
干预措施: phenylephrine solution (Drug)
10.0 mg phenylephrine
Experimental
干预措施: phenylephrine solution (Drug)
20.0 mg phenylephrine
Experimental
干预措施: phenylephrine solution (Drug)
40.0 mg phenylephrine
Experimental
干预措施: phenylephrine solution (Drug)
60.0 mg phenylephrine
Experimental
干预措施: phenylephrine solution (Drug)
80.0 mg phenylephrine
Experimental
干预措施: phenylephrine solution (Drug)
结局指标
主要结局
Safety: the presence or absence of mucosal or systemic toxicity related the the topical application of phenylephrine.
时间窗: 24 months
次要结局
- Efficacy: the the mucositis severity area-under-the-curve (AUC) where the severity of oral mucositis on each treatment day will be scored, summed, and plotted graphically.(24 months)
研究者
研究点 (1)
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