NCT04214769Unknown不适用
Evaluation of the Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function Using Novel Techniques
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 17
- 主要终点
- VEMP test
研究概览
简要总结
Aims: 1. To evaluate the effects of radiation therapy on the inner ear, among patients treated with radiation therapy for head and neck cancers using a wide battery of tests (Audiometry and tympanometry, vHIT, VEMP, ENG) ; 2. To correlate the mean total radiation dose to the cochlea with the effects on audiological and vestibular function
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Females and males, Age: ≥ 18 years old
- •Patients diagnosed Head and Neck cancers, not treated previously
- •Planned for radiation therapy in which the inner ear will be radiated
排除标准
- •Patients who were previously diagnosed with a vestibular disorder
- •Previous middle or inner ear anomaly
- •Failure to complete the whole course of radiation therapy
- •More than one course of radiation therapy
- •Patients treated with concurrent ototoxic chemotherapy
- •Pregnant women
- •Patients who will not sign an informed consent form
- •Helpless or incompetent patients
结局指标
主要结局
VEMP test
时间窗: 1.5 Year
Abnormal latencies, amplitudes, thresholds
Audiometry
时间窗: 1.5 Year
The change in hearing threshold and in the speech-audiometry
ENG test
时间窗: 1.5 Year
Abnormal function of the central vestibular pathways, unilateral weakness of the vestibular apparatus or direction preponderance
vHIT test
时间窗: 1.5 Year
abnormal gain, the appearance of overt and covert saccades
次要结局
未报告次要终点
研究者
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