taVNS for Breast Cancer Pain and Symptom Management

Official title

Home-based Pain and Symptom Management for Breast Cancer Survivors: a Triple- Blinded RCT Pilot Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Overview

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.

Interventions

• Device Active taVNS
  practice the active 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)

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Change in pain intensity and interference [Time frame: Baseline and 4 weeks and 8 weeks]
• Change in chronic pain self-efficacy [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in quantitative sensory testing (QST) [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in conditioned pain modulation (CPM) [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in symptoms: Physical Function [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in symptoms: Anxiety [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in symptoms: Depression [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in symptoms: Fatigue [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in symptoms: Sleep Disturbance [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in symptoms: Ability to Participate in Social Roles and Activities [Time frame: Baseline and 4 weeks and 8 weeks]
• Changes in pain-related cortical response [Time frame: 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 [Time frame: Baseline and 4 weeks and 8 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Florida State University — Tallahassee

Identifiers

NCT: NCT07500012 · STUDY00006413

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗