taVNS for Breast Cancer Pain and Symptom Management
This study is looking at whether a device called transcutaneous auricular Vagus Nerve Stimulation (taVNS) can help breast cancer survivors with pain and other symptoms. taVNS is a device that gently stimulates a nerve in your ear. You would use either the active taVNS device or a sham (inactive) taVNS device twice a day for 30 minutes over 4 weeks. We want to see if it's practical for people to use this device at home, how well they stick to the schedule, and if there are any side effects. We're also interested in how taVNS might affect pain, anxiety, depression, fatigue, and the connection between the brain and gut. You may be able to join if you are a woman aged 18-79 who has completed primary treatment for Stage 0, I, II, or III breast cancer and are on a stable survivorship care plan. The study plans to enroll 40 participants, but its current status is unclear.
- Study design
- This is an interventional study with 40 planned participants. It compares an active taVNS device to a sham taVNS device.
- What's involved
- You would practice using the taVNS device twice daily for 30 minutes each, over a 4-week period, for a total of 56 sessions. Your retention and adherence will be measured at baseline, 4 weeks, and 8 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and tolerability at baseline, 4 weeks, and 8 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
taVNS for Breast Cancer Pain and Symptom Management
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Feasibility of implementing taVNS - Retention ratesBaseline and 4 weeks and 8 weeks
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.
- Adherence of implementing taVNS - Duration of usage4 weeks
Participants will log the frequency, time, and duration of daily taVNS device use in an online diary through the REDCap system.
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)Baseline and 4 weeks and 8 weeks
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.
- Satisfaction in implementing taVNSBaseline and 4 weeks and 8 weeks
Satisfaction in using the taVNS will be measured using self-reported data including online self-monitoring diary, surveys, and interviews.