Alopecia Prevention Trial of Topical Vasoconstrictor Therapy in Head and Neck Cancer Patients Treated With Intensity Modulated Radiotherapy (IMRT)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety of daily topical application of norepinephrine to the radiation field.
研究概览
简要总结
The study will evaluate the safety of topical norepinephrine in head and neck cancer patients who are receiving treatment with intensity modulated radiotherapy (IMRT).
The study will also provide information about whether topical norepinephrine can prevent or decrease the severity of the radiation-induced alopecia experienced by these patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be ≥ 18 years of age with documented pathological diagnosis of H&N (head and neck) cancer.
- •planned to receive H&N region IMRT treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to be at least 20 Gy.
- •have a palpable nuchal prominence (external occipital protuberance)
- •have the ability to understand the informed consent document.
- •be able to comply with protocol schedule.
- •have a negative serum pregnancy test if a female of childbearing potential.
- •consent to utilize medically acceptable methods of contraception throughout the study if of childbearing potential.
- •be treated with IMRT alone or with concurrent platinum based chemotherapy
- •receive definitive treatment for oropharyngeal squamous cell carcinoma
排除标准
- •with clinical or radiographic evidence of adenopathy to the high level V posterior cervical nodes, post-auricular or occipital cervical nodal stations
- •planned to receive H&N region treatment in which the mean dose to the dermis in the scalp risk zone (isodose plan) is estimated to exceed 50Gy
- •with underlying active untreated cardiac disease (e.g. arrhythmia)
- •receiving concurrent chemotherapy other than single agent platinum based
- •with generalized skin disorders that have required treatment within the past 6 months.
- •with connective tissue disorders
- •with unhealed wounds or scars in the study area
- •with rashes, ulcerations, or poorly healed scars in the treatment area
- •with a known allergy to norepinephrine
- •with a known clinically significant abnormal ECG (electrocardiogram) within the past 6 months.
- •taking MAO (monoamine oxidase) inhibitors or antidepressants of the triptyline or imipramine types
- •taking β-blockers
- •with NCI-CTCAE Version 4.0 grade 2 or higher hypertension at the time of study entry.
研究组 & 干预措施
Norepinephrine
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Safety of daily topical application of norepinephrine to the radiation field.
时间窗: Safety will be assessed during the study (6-7 weeks) and at follow-up visits approximately 2 and 4 weeks after the end of the treatment period.
The primary safety hypothesis is that there will be that there will be little or no scalp irritation associated with the application of the topical norepinephrine and that there will be no systemic effects secondary to transdermal absorption.
次要结局
- Efficacy of daily topical application of norepinephrine to the radiation field.(Efficacy will be assessed during the study (6-7 weeks) and at follow-up visits approximately 2 and 4 weeks after the end of the treatment period)