taVNS for Breast Cancer Pain and Symptom Management

Florida State University

Status: Enrolling

Conditions: Breast Cancer Survivors

Treatments: Device: Active taVNS; Device: Sham taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT07500012

STUDY00006413

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Active taVNS intervention

Active Comparator group

Description:

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

Treatment:

Device: Active taVNS

Sham taVNS

Sham Comparator group

Description:

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

Treatment:

Device: Sham taVNS