Feasibility and Expansion Trial of Transcutaneous Vagus Nerve Stimulation (tVNS) for Immune-Related Fatigue in Patients Receiving Immune Checkpoint Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 13
- 主要终点
- Feasibility of Daily tVNS Use
研究概览
简要总结
This study evaluates whether a non-invasive device called transcutaneous vagus nerve stimulation (tVNS) can be safely and feasibly used to help reduce fatigue in patients receiving immunotherapy for cancer. Fatigue is a common and often severe side effect of immune checkpoint inhibitors, and there are currently limited effective treatment options.
In this study, participants will use a small device at home that delivers mild electrical stimulation to the ear for 60 minutes each day over a 6-week period. The study will assess whether patients are able to use the device as prescribed (feasibility), how well it is tolerated, and whether it may improve fatigue and quality of life.
The study will also explore changes in biological markers of inflammation and measures of nervous system function to better understand how tVNS may work. The results of this study will help determine whether this approach should be tested in larger future trials.
详细描述
This is a single-arm, open-label feasibility and expansion study evaluating transcutaneous vagus nerve stimulation (tVNS) as a supportive care intervention for immune-related fatigue in patients receiving immune checkpoint inhibitor therapy.
Eligible participants are adults with advanced or metastatic solid tumors who are currently receiving immune checkpoint inhibitors and experiencing clinically significant fatigue. Participants will self-administer tVNS at home once daily for 60 minutes over a 6-week intervention period using a non-invasive auricular stimulation device.
The primary objective is to evaluate feasibility, defined as adherence to the prescribed tVNS regimen. Secondary objectives include assessment of safety and tolerability, as well as changes in fatigue severity and health-related quality of life. Exploratory objectives include evaluation of changes in autonomic function, measured by heart rate variability, and inflammatory biomarkers obtained from blood samples.
Participants will complete study visits at baseline, Week 3, and Week 6, which include patient-reported outcome measures, adverse event assessments, and biospecimen collection. Heart rate variability will be continuously monitored using a wearable device throughout the intervention period.
This study is designed to generate feasibility and preliminary clinical and biological data to inform the design of future randomized trials evaluating tVNS as a treatment for immune-related fatigue.
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
- •Age 18 years or older
- •Histologically confirmed advanced or metastatic solid tumor
- •Receiving immune checkpoint inhibitor therapy and completed at least two cycles
- •Clinically significant fatigue (FACIT-F score ≤ 34)
- •ECOG performance status 0-2
- •Life expectancy of at least 3 months
- •Ability to provide informed consent
- •Access to a smartphone or tablet
排除标准
- •Current or planned chemotherapy, targeted therapy, or radiation during the 4-week intervention period.
- •Have received targeted therapy in the last 2 weeks
- •Have received chemotherapy or radiation therapy in the last 4 weeks
- •Symptomatic brain metastases defined as active neurologic complaint (headache, blurry vision, neurologic deficits or other symptom requiring treatment with steroids)
- •Long term steroid use >10 mg prednisone equivalent daily
- •Active autoimmune disease requiring systemic immunosuppression
- •Implanted electronic medical devices (e.g., pacemakers, defibrillators)
- •History of epilepsy or vagal hypersensitivity
- •Known arrhythmia or bradycardia (Baseline HR < 50 bpm)
- •Open wounds or dermatologic issues at the stimulation site
- •Pregnancy or breastfeeding
- •Participation in other fatigue-focused intervention trials
- •Severe uncontrolled psychiatric illness (PHQ-9 >20)
研究组 & 干预措施
Transcutaneous Vagus Nerve Stimulation (tVNS)
Participants will self-administer transcutaneous vagus nerve stimulation (tVNS) at home using a non-invasive auricular stimulation device for 60 minutes per day over a 6-week period. Participants will continue standard cancer therapy, including immune checkpoint inhibitors, during the study. Study assessments will include adherence monitoring, adverse event evaluation, patient-reported outcomes, and collection of blood samples and physiologic data.
干预措施: Participants will self-administer transcutaneous vagus nerve stimulation (tVNS) at home using a non-invasive auricular stimulation device for 60 minutes per day over a 6-week period. Participants will (Device)
结局指标
主要结局
Feasibility of Daily tVNS Use
时间窗: Up to 6 weeks
Feasibility will be assessed based on adherence to the prescribed tVNS regimen. Feasibility is defined as the proportion of participants who complete at least 80% of prescribed tVNS sessions over the 6-week intervention period, as measured by concordance between participant-reported use and device-recorded usage.
次要结局
- Safety and Tolerability of tVNS(Up to 6 weeks)
- Change in Fatigue Severity (FACIT-F)(Baseline to 6 weeks)
- Change in Health-Related Quality of Life (EORTC QLQ-C30)(Health-related quality of life will be assessed using the EORTC QLQ-C30 global health status scale. Changes from baseline to Week 6 will be evaluated.)
- Change in Heart Rate Variability(Baseline to 6 weeks)
- Change in Inflammatory Biomarkers(Baseline to 6 weeks)
研究者
Rohit Singh
Assistant Professor
University of Vermont Medical Center