taVNS for Breast Cancer Pain and Symptom Management
Home-based Pain and Symptom Management for Breast Cancer Survivors: a Triple- Blinded RCT Pilot Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Florida State University
40 participants
Feb 24, 2026
INTERVENTIONAL
Conditions
Summary
1. To evaluate the feasibility and acceptability of a home-based taVNS intervention and follow-up for pain and symptom management in breast cancer survivors. 2. To investigate the impact of taVNS on secondary outcomes, including pain, anxiety, depression, fatigue, and the brain-gut axis (BGA) in breast cancer survivors.
Eligibility
Inclusion Criteria8
- are aged 18-79 years older;
- have histologically confirmed Stage 0, I, II, or III breast cancer;
- had completed their primary cancer treatment (surgery, radiotherapy, chemotherapy) and are currently on a stable survivorship care plan (e.g., endocrine therapy, supportive care), with no major treatment changes expected during the study;
- have experienced pain with a severity of 4 or greater out of 10 for at least ten days in the last month;
- are committed to maintaining the current treatment plan (e.g., endocrine therapy, supportive care) during the study;
- have reliable internet access;
- are willing to provide stool samples and undergo fNIRS brain imaging procedures;
- are able to read and understand English and provide written informed consent.
Exclusion Criteria11
- have metastatic breast cancer (Stage IV);
- have a current diagnosis of another active cancer;
- have a history of significant cardiac conditions, such as bradycardia, arrhythmia, recent myocardial infarction, or heart failure;
- have been diagnosed with a severe psychiatric illness (e.g., schizophrenia, bipolar I disorder with active psychosis) that could interfere with adherence to study procedures;
- have active inflammatory or malabsorptive gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease) that could confound gut microbiota results;
- have taken antibiotics, probiotics, or gastrointestinal motility agents (e.g., laxatives, prokinetics) within the past 3 months, due to potential disruption of gut microbiota;
- have a progressive neurological condition (e.g., Parkinson's disease, epilepsy, multiple sclerosis) that may impact fNIRS data quality or study participation;
- have a history of surgical or pharmacological vagotomy or are currently receiving implanted vagus nerve stimulation therapy, because of potential interference with autonomic regulation and taVNS mechanisms;
- have an active electronic or metallic implant (e.g., cochlear implant, pacemaker, neurostimulator) or other electronic/metallic device in the head or neck area, which may be contraindicated for taVNS;
- are pregnant, breastfeeding, or planning to become pregnant during the study period;
- have had a recent initiation or dose change of pain medications (e.g., opioids, neuropathic agents) within the past 4 weeks.
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Interventions
practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07500012