Actively Recruiting

Phase Not Applicable
Age: 18Years - 79Years
FEMALE
NCT07500012

taVNS for Breast Cancer Pain and Symptom Management

Led by Florida State University · Updated on 2026-03-30

40

Participants Needed

1

Research Sites

101 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

taVNS for Breast Cancer Pain and Symptom Management

Who Can Participate

Age: 18Years - 79Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 79 years
  • Histologically confirmed Stage 0, I, II, or III breast cancer
  • Completed primary cancer treatment and on a stable survivorship care plan with no major changes expected
  • Experienced pain rated 4 or higher out of 10 for at least ten days in the past month
  • Committed to maintaining current treatment plan during the study
  • Have reliable internet access
  • Willing to provide stool samples and undergo brain imaging (fNIRS)
  • Able to read and understand English and provide written informed consent
Not Eligible

You will not qualify if you...

  • Metastatic breast cancer (Stage IV)
  • Current diagnosis of another active cancer
  • History of significant cardiac conditions (e.g., bradycardia, arrhythmia, recent myocardial infarction, heart failure)
  • Severe psychiatric illness that may affect study adherence
  • Active inflammatory or malabsorptive gastrointestinal disorders
  • Use of antibiotics, probiotics, or gastrointestinal motility agents within the past 3 months
  • Progressive neurological conditions affecting data quality or participation
  • History of surgical or pharmacological vagotomy or current implanted vagus nerve stimulation therapy
  • Active electronic or metallic implant in the head or neck area
  • Pregnant, breastfeeding, or planning pregnancy during the study
  • Recent initiation or dose change of pain medications within the past 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Florida State University

Tallahassee, Florida, United States, 32306

Actively Recruiting

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Research Team

J

Jie Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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taVNS for Breast Cancer Pain and Symptom Management | DecenTrialz