taVNS for Breast Cancer Pain and Symptom Management

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Breast Cancer Survivors

In brief

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.

Key facts

Study ID

NCT07500012

Run by

Florida State University

People needed

40

Starts

2026-02-24

Expected to finish

2028-02-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 79. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Florida State University — Tallahassee, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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