Actively Recruiting
Home-based Pain and Symptom Management for Breast Cancer Survivors: a Triple-Blinded RCT Pilot Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Led by Florida State University · Updated on 2026-03-30
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention to manage pain and symptoms in breast cancer survivors. The study aims to assess how feasible and acceptable this treatment is, while also examining its effects on pain, anxiety, depression, fatigue, and the brain-gut axis in this population. This is a randomized, double-blinded clinical trial sponsored by Florida State University. Participants will be randomly assigned to either an active taVNS group or a sham taVNS group. Both groups will practice their assigned intervention twice daily for 30 minutes each session over a 4-week period, totaling 56 sessions. The study includes baseline, 4-week, and 8-week assessments to monitor outcomes and potential side effects. During the study, participants will be monitored for treatment adherence, safety, and satisfaction. Researchers will measure changes in pain intensity, chronic pain self-efficacy, sensory testing, anxiety, depression, fatigue, sleep disturbance, social participation, and brain responses related to pain. Stool samples and brain imaging using fNIRS will be collected to evaluate gut microbiota and brain activity. The total study duration per participant includes follow-ups at 4 and 8 weeks to assess all outcomes and safety.
CONDITIONS
Brief Title
taVNS for Breast Cancer Pain and Symptom Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 79 years
- Histologically confirmed Stage 0, I, II, or III breast cancer
- Completed primary cancer treatment and currently on a stable survivorship care plan
- Experienced pain rated 4 or greater out of 10 for at least ten days in the last month
- Committed to maintaining current treatment plan during the study
- Have reliable internet access
- Willing to provide stool samples and undergo fNIRS brain imaging
- Able to read and understand English and provide written informed consent
You will not qualify if you...
- Metastatic breast cancer (Stage IV)
- Current diagnosis of another active cancer
- History of significant cardiac conditions such as bradycardia, arrhythmia, recent myocardial infarction, or heart failure
- Severe psychiatric illness that may interfere with study adherence
- Active inflammatory or malabsorptive gastrointestinal disorders
- Use of antibiotics, probiotics, or gastrointestinal motility agents within the past 3 months
- Progressive neurological conditions impacting study participation or data quality
- History of surgical or pharmacological vagotomy or current implanted vagus nerve stimulation therapy
- Active electronic or metallic implant in the head or neck area contraindicating taVNS
- Pregnant, breastfeeding, or planning pregnancy during the study
- Recent initiation or dose change of pain medications within the past 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants practice either active or sham transcutaneous auricular vagus nerve stimulation (taVNS) twice daily for 30 minutes each over a 4-week period.
Daily sessions at home, with 1 baseline and 2 follow-up visits (at 4 weeks and 8 weeks)
Duration - 4 weeks
Participants are monitored for retention, adherence, safety, and symptom changes after the 4-week intervention.
1 follow-up visit (at 8 weeks)
Trial Site Locations
Total: 1 location
1
Florida State University
Tallahassee, Florida, United States, 32306
Actively Recruiting
Research Team
J
Jie Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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