taVNS for Breast Cancer Pain and Symptom Management

ConditionBreast Cancer Survivors

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-79

SponsorFlorida State University

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

Active taVNS
Sham taVNS

Treatment groups

40 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Florida State University

Lead sponsor

Source ClinicalTrials.gov