Impact of Immunotherapy on Vestibular Function, The Mayo Clinic Arizona Experience
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in clinically significant vestibulopathy - vestibular function
研究概览
简要总结
This study evaluates the impact of immunotherapy on balance in patients receiving immunotherapy as part of their standard of care.
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
- •At least 18 years of age at screening
- •Patients who will be initiating single agent immunotherapy with pembrolizumab, cemiplimab, nivolumab, atezolizumab, or dual therapy with (Ipilimumab/Nivolumab or Nivolumab/Relatlimab)
排除标准
- •Concurrent chemotherapy
研究组 & 干预措施
Observational
Patients undergo vestibular function testing with video head impulse testing, sinusoidal harmonic acceleration testing, and pure tone audiometry and complete questionnaires throughout the study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Change in clinically significant vestibulopathy - vestibular function
时间窗: Baseline, 3 months, 6 months, 12 months
Assessed using standard vestibular function testing. Results will be aggregated to determine overall vestibular function. Results from baseline (prior to initiating immunotherapy) will be compared to results at 3, 6, and 12 months.
Change in clinically significant vestibulopathy - vestibular function
时间窗: Baseline, 3 months, 6 months, 12 months
Assessed using standard vestibular function testing. Results will be aggregated to determine overall vestibular function. Results from baseline (prior to initiating immunotherapy) will be compared to results at 3, 6, and 12 months.
Change in clinically significant vestibulopathy - hearing level
时间窗: Baseline,12 months
Assessed using Pure Tone Audiometry, a standard hearing test. Any change from baseline (prior to initiating immunotherapy) to 12 months will be reported.
Oscillopsia Severity Questionnaire (OSQ)
时间窗: Baseline, 3 months, 6 months, 12 months
The OSQ consists of 9 questions to assess visual environment sensation (episodes of oscillopsia). Questions are answered on a 5-point scale: always, often, sometimes, seldom, never. The OSQ is scored by calculating a mean item score, which results in a total score ranging from 1 to 5. A score of 3 or higher indicates moderate to extreme oscillopsia severity.
次要结局
未报告次要终点