taVNS for Breast Cancer Pain and Symptom Management

Florida State University40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer Survivors

Interventions

Active taVNSDEVICE

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

Sham taVNSDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (1)

Florida State University

Tallahassee, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 4 weeks and 8 weeks

Secondary Outcomes

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.

Central Contacts

Jie Chen

CONTACT

850-645-0657 jc22db@fsu.edu

Data from ClinicalTrials.gov

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