RecruitingNot ApplicableNCT07500012

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)


Sponsor

Florida State University

Enrollment

40 participants

Start Date

Feb 24, 2026

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 79 Years

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

DEVICEActive taVNS

practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)

DEVICESham taVNS

practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)


Locations(1)

Florida State University

Tallahassee, Florida, United States

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NCT07500012


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