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)
Who can join
Ages 18 to 79 · Women
Full eligibility criteria
Inclusion Criteria: 1. are aged 18-79 years older; 2. have histologically confirmed Stage 0, I, II, or III breast cancer; 3. 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; 4. have experienced pain with a severity of 4 or greater out of 10 for at least ten days in the last month; 5. are committed to maintaining the current treatment plan (e.g., endocrine therapy, supportive care) during the study; 6. have reliable internet access; 7. are willing to provide stool samples and undergo fNIRS brain imaging procedures; 8. are able to read and understand English and provide written informed consent. Exclusion Criteria: 1. have metastatic breast cancer (Stage IV); 2. have a current diagnosis of another active cancer; 3. have a history of significant cardiac conditions, such as bradycardia, arrhythmia, recent myocardial infarction, or heart failure; 4. 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; 5. have active inflammatory or malabsorptive gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease) that could confound gut microbiota results; 6. have taken antibiotics, probiotics, or gastrointestinal motility agents (e.g., laxatives, prokinetics) within the past 3 months, due to potential disruption of gut microbiota; 7. have a progressive neurological condition (e.g., Parkinson's disease, epilepsy, multiple sclerosis) that may impact fNIRS data quality or study participation; 8. 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; 9. 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; 10. are pregnant, breastfeeding, or planning to become pregnant during the study period; 11. have had a recent initiation or dose change of pain medications (e.g., opioids, neuropathic agents) within the past 4 weeks.
About the study
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.
What is being tested
- Active taVNS (device)
- Sham taVNS (device)
Sponsor: Florida State University · Participants: 40 · Started: Feb 24, 2026
Contact the study team
- Jie Chen · Phone: 850-645-0657
Official record on ClinicalTrials.gov — NCT07500012
Locations in the U.S.
| Florida | Florida State University, Tallahassee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.