Home-based ear vagus nerve stimulation for breast cancer pain and symptoms
Home-based Pain and Symptom Management for Breast Cancer Survivors: a Triple- Blinded RCT Pilot Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
This trial will test whether a handheld at-home transcutaneous auricular vagus nerve stimulation (taVNS) device can reduce pain and other symptoms in breast cancer survivors with ongoing moderate pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | Female |
| Sponsor | Florida State University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT07500012 on ClinicalTrials.gov |
What this trial studies
Breast cancer survivors who have completed primary treatment and report persistent pain will be assigned to use either an active or a sham taVNS device at home while continuing usual care. Symptom outcomes including pain, anxiety, depression, and fatigue will be collected alongside biological measures of the brain–gut axis, including stool samples and fNIRS brain imaging performed at the study site. The protocol emphasizes remote delivery with device training, home use, and follow-up to determine feasibility and acceptability of a home-based intervention. The study will compare symptom changes and mechanistic markers between the active and sham groups.
Who should consider this trial
Good fit: Ideal candidates are English-speaking breast cancer survivors aged 18–79 with non-metastatic (Stage 0–III) disease who have finished primary treatment, report pain ≥4/10 for at least ten days in the past month, have reliable internet, and are willing to provide stool samples and undergo fNIRS imaging.
Not a fit: Patients with metastatic (Stage IV) disease, another active cancer, significant cardiac conditions, inability to use the device or lack internet access, or those with only mild pain are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, home taVNS could offer a non-drug option to reduce chronic pain and related symptoms and improve daily function for breast cancer survivors.
How similar studies have performed: Small pilot studies of taVNS and other noninvasive vagus nerve stimulation approaches have reported preliminary benefits for pain and mood, but larger controlled trials are still limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tallahassee, Florida
- Florida State University — Tallahassee, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Jie Chen
- Email: jc22db@fsu.edu
- Phone: 850-645-0657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.