Home-based Pain and Symptom Management for Breast Cancer Survivors: a Triple- Blinded RCT Pilot Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Florida State University
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.
Eligibility
- Age range
- 18–79 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- DeviceActive taVNS
practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
- DeviceSham taVNS
practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
Location
- Florida State UniversityTallahassee, Florida