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.
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)
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)
Single group
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
DeviceParticipants 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.
Feasibility of Daily tVNS Use
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.
Safety and Tolerability of tVNS
Safety and tolerability will be assessed by the incidence, severity, and relatedness of adverse events occurring during the 6-week intervention period, graded according to CTCAE version 5.0.
Change in Fatigue Severity (FACIT-F)
Fatigue severity will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale. Changes in scores from baseline to Week 6 will be evaluated.
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
Autonomic function will be assessed using heart rate variability (HRV) derived from wearable device data collected throughout the 6-week intervention period. Changes in HRV metrics over time will be explored.
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This trial is not recruiting at the moment. You can still explore other options:
