taVNS for Breast Cancer Pain and Symptom Management

NCT07500012 | Recruiting FDA Device

• 1 other identifier: STUDY00006413
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Breast Cancer Survivors

Keywords

pain; symptoms; transcutaneous auricular vagus nerve stimulation (taVNS)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Change in pain intensity and interference

  Baseline and 4 weeks and 8 weeks

• Change in chronic pain self-efficacy

  Baseline and 4 weeks and 8 weeks

• Changes in quantitative sensory testing (QST)

  Baseline and 4 weeks and 8 weeks

• Changes in conditioned pain modulation (CPM)

  Baseline and 4 weeks and 8 weeks

• Changes in symptoms: Physical Function

  Baseline and 4 weeks and 8 weeks

Study Arms (2)

Active taVNS intervention

ACTIVE COMPARATOR

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

Device: Active taVNS

Sham taVNS

SHAM COMPARATOR

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

Device: Sham taVNS

Interventions

Active taVNS DEVICE

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

Active taVNS intervention

Sham taVNS DEVICE

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

Sham taVNS

Eligibility Criteria

• Age: 18 Years - 79 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jie Chen

CONTACT

850-645-0657; jc22db@fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 30, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)