Neuromodulation of Cardiovascular Risks Associated With Cardiotoxic Chemotherapy: A First in Human Randomized Pilot Study. Neuromodulation in Cancer Study (OU-SCC-NCAN)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
研究概览
简要总结
This study is to determine if low level vagus nerve stimulation will lead to improvement in heart function, heart rate variation, and in the levels of certain chemical markers of inflammation in study participants' blood.
详细描述
Patients will be asked to use a handheld electrical unit (stimulator) at home to deliver vagus nerve stimulation (low level stimulation) to one ear for a period of 1 hour for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (>18 years) who have received anthracycline-based therapy for breast cancer or lymphoma within the last 30 days
- •A least 1 of following additional criteria:
- •previous chest radiation
- •type 2 diabetes mellitus
- •hypertension
- •current smoking
- •obesity (BMI ≥ 30)
- •previous myocardial infarction
- •established atherosclerotic heart disease or significant valve disease. chronic kidney disease
排除标准
- •Atrial paced rhythm
- •History of seizure currently on treatment
- •History of vasovagal syncope
- •End stage liver or kidney disease
研究组 & 干预措施
Self administration of Low Level Tragus Stimulation (LLTS; Placebo)
PARASYM neuromodulation device will be placed in a pre-determined position of one ear for 1 hour every day for 14 days.
干预措施: PARASYM neuromodulation device (Device)
Self administration of LLTS
PARASYM neuromodulation device will be placed in a pre-determined position (different from that of the placebo) of one ear for 1 hour every day for 14 days.
干预措施: PARASYM neuromodulation device (Device)
结局指标
主要结局
Effects of low-level tragus stimulation (LLTS) on global longitudinal strain (GLS)
时间窗: 2 weeks
An echocardiogram will be performed on patients at baseline and at follow up (14 days after start of intervention). The percentage change of GLS and left ventricular ejection fraction (LVEF) will be compared at baseline and follow up in patients receiving cardiotoxic chemotherapy.
次要结局
- Effects of LLTS on oxidative stress(2 weeks)
- Effects of LLTS on autonomic tone(2 weeks)