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)