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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Florida State University
RECRUITING
Tallahassee
Contact Information
Primary
Jie Chen
jc22db@fsu.edu
850-645-0657
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2028-02
Participants
Target number of participants: 40
Treatments
Active_comparator: Active taVNS intervention
practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
Sham_comparator: Sham taVNS
practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)
Related Therapeutic Areas
Sponsors
Leads: Florida State University

This content was sourced from clinicaltrials.gov