Home-Based Transcutaneous Auricular Vagus Nerve Stimulation for Pain and Symptom Relief in Female Breast Cancer Survivors Aged 18 to 79

What this Trial Is About

Researchers are evaluating a home-based transcutaneous auricular vagus nerve stimulation taVNS intervention to manage pain and symptoms in breast cancer survivors. The study aims to assess how feasible and acceptable this treatment is, while also examining its effects on pain, anxiety, depression, fatigue, and the brain-gut axis in this population. This is a randomized, double-blinded clinical trial sponsored by Florida State University. Participants will be randomly assigned to either an active taVNS group or a sham taVNS group. Both groups will practice their assigned intervention twice daily for 30 minutes each session over a 4-week period, totaling 56 sessions. The study includes baseline, 4-week, and 8-week assessments to monitor outcomes and potential side effects. During the study, participants will be monitored for treatment adherence, safety, and satisfaction. Researchers will measure changes in pain intensity, chronic pain self-efficacy, sensory testing, anxiety, depression, fatigue, sleep disturbance, social participation, and brain responses related to pain. Stool samples and brain imaging using fNIRS will be collected to evaluate gut microbiota and brain activity. The total study duration per participant includes follow-ups at 4 and 8 weeks to assess all outcomes and safety.

taVNS for Breast Cancer Pain and Symptom Management