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)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Survivors
• Intervention / Treatment: Device: Active taVNS; Device: Sham taVNS

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Chen; Phone Number: 850-645-0657; Email: jc22db@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Recruiting
      • Florida State University
      • Contact: JIE CHEN; Phone Number: 8506450657; Email: jc22db@fsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active taVNS intervention; practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)	Device: Active taVNS; practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
Sham Comparator: Sham taVNS; practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)	Device: Sham taVNS; practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing taVNS - Retention rates	Feasibility will be assessed by evaluating the retention rate of participants who complete the taVNS sessions at 4 weeks and the follow-up at week 8. Retention rates will be calculated by comparing the number of participants who complete these timepoints with the baseline data.	Baseline and 4 weeks and 8 weeks
Adherence of implementing taVNS - Duration of usage	Participants will log the frequency, time, and duration of daily taVNS device use in an online diary through the REDCap system.	4 weeks
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in using the taVNS will be measured using self-reported data, including online self-monitoring diary, surveys, and interviews. Adverse events (AEs) will be monitored daily using the online diary with a preset form, including a 10-item survey to assess daily AEs of taVNS on 0-10 Likert scales.	Baseline and 4 weeks and 8 weeks
Satisfaction in implementing taVNS	Satisfaction in using the taVNS will be measured using self-reported data including online self-monitoring diary, surveys, and interviews.	Baseline and 4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity and interference	Pain Inventory (BPI) will be used to assess the multidimensional aspects of pain, its location, intensity, and interference. A higher score indicated higher pain intensity with 0 indicating no pain and 10 indicating the worst pain. A higher score of pain interference means daily functions are more impacted by pain, and 0 indicates no pain interference, and 10 means the worst pain interference.	Baseline and 4 weeks and 8 weeks
Change in chronic pain self-efficacy	Chronic Pain Self-Efficacy Scale (CPSES) will be used to measure pain self-efficacy with scores from 0-100, higher scores indicating improved self-efficacy.	Baseline and 4 weeks and 8 weeks
Changes in quantitative sensory testing (QST)	Quantitative sensory testing (QST) will be used to measure sensitivity to experimental pain with standardized stimuli to test both nociceptive and non-nociceptive systems.	Baseline and 4 weeks and 8 weeks
Changes in conditioned pain modulation (CPM)	CPM will be used to determine the net effect of various facilitating and inhibiting systems exerting their activity at spinal or supraspinal levels. A phasic noxious stimulus (cold) will be applied in conjunction with a tonic noxious conditioning stimulus (pressure) applied to a distant body site on the forearm. Participants' self-reported pain intensity by NRS during the test will be recorded.	Baseline and 4 weeks and 8 weeks
Changes in symptoms: Physical Function	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the physical function. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 4 weeks and 8 weeks
Changes in symptoms: Anxiety	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the anxiety. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 4 weeks and 8 weeks
Changes in symptoms: Depression	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring depression. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 4 weeks and 8 weeks
Changes in symptoms: Fatigue	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring fatigue. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 4 weeks and 8 weeks
Changes in symptoms: Sleep Disturbance	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the co-occurring sleep disturbance. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 4 weeks and 8 weeks
Changes in symptoms: Ability to Participate in Social Roles and Activities	The Patient-Reported Outcomes Measurement Information System (PROMIS) profile will be used to measure the the ability to participate in social roles and activities. The T-score of PROMIS measurement ranges from 0 to 100 and a higher T-score indicates a more severe symptom reported by the subjects. A T-score greater than 50 means participants have more severe symptoms than the healthy population.	Baseline and 4 weeks and 8 weeks
Changes in pain-related cortical response	Cortical activity associated with pain stimuli will be assessed utilizing a continuous-wave, multichannel functional near-infrared spectroscopy (fNIRS) imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) equipped with three semiconductor lasers emitting at 780, 805, and 830 nm. Optical data will be gathered while subjects undergo thermal pain stimulation.	Baseline and 4 weeks and 8 weeks
Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut	The 16S rRNA V4 region will be amplified and sequenced by using stool samples to depict the fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut.	Baseline and 4 weeks and 8 weeks

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pain; symptoms; transcutaneous auricular vagus nerve stimulation (taVNS)
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: STUDY00006413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified data will be available upon reasonable request. Requests to access these datasets should be directed to jc22db@fsu.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes