Recruiting

taVNS

Sponsor:

Florida State University

Code:

NCT07500012

Conditions

Breast Cancer Survivors

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active taVNS

Sham taVNS

Study Details

Brief 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.

Conditions

Breast Cancer Survivors

Study ID

NCT07500012

Start date

Feb 24, 2026

Status verified date

Mar, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Active taVNS intervention

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)

Interventions

Active taVNS

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

Sham taVNS

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

Primary outcome measure

  • Feasibility of implementing taVNS - Retention rates [ Time Frame: Baseline and 4 weeks and 8 weeks ]
  • Adherence of implementing taVNS - Duration of usage [ Time Frame: 4 weeks ]
  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: Baseline and 4 weeks and 8 weeks ]
  • Satisfaction in implementing taVNS [ Time Frame: Baseline and 4 weeks and 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

More Information

Sponsor

Florida State University

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-03-30.