Clinical Application of Vagus Nerve Stimulation Combined With Immunoregulatory T Cells in Allevia… (NCT07593365) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Application of Vagus Nerve Stimulation Combined With Immunoregulatory T Cells in Alleviating Aromatase Inhibitor-Induced Pain
China216 participantsStarted 2026-05-06
Plain-language summary
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation, also called taVNS, can help relieve aromatase inhibitor-related joint and muscle pain in adult women with hormone receptor-positive breast cancer.
The main questions this study aims to answer are:
1. Does taVNS reduce pain caused by aromatase inhibitor treatment?
2. Does taVNS improve quality of life, mood symptoms, and the need for pain medicine?
3. What side effects or medical problems occur during treatment?
Researchers will compare active taVNS with sham stimulation. Participants in both groups will receive mild electrical stimulation around the ear, but the sham stimulation will be applied to an area not expected to activate the vagus nerve.
Participants will:
1. Be randomly assigned to active taVNS or sham stimulation
2. Receive one 30-minute treatment session every day for 28 days
3. Complete pain, mood, and quality-of-life questionnaires before treatment, after treatment, and during follow-up
4. Report pain medicine use and any side effects
5. Provide small blood samples to measure inflammatory markers, T-cell profiles, and tumor markers
Participants will be followed for up to 6 months after treatment. For some participants who do not have enough pain relief after taVNS, an optional second-stage study may be offered. In this stage, participants may receive low-dose interleukin-2, also called IL-2, by injection every other day for 2 weeks.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female participants aged over 18 years;
. Patients with pathologically confirmed stage I-III primary breast cancer;
. Patients who have recovered from systemic symptoms related to surgery, radiotherapy, or chemotherapy;
. Patients with estrogen receptor- and/or progesterone receptor-positive breast cancer who are receiving aromatase inhibitor therapy and have aromatase inhibitor-related musculoskeletal pain, with a score greater than 3 on the Worst Pain item of the Brief Pain Inventory (BPI-WP);
. Patients who have received aromatase inhibitor therapy for more than 30 days and are expected to continue treatment for more than 1 year;
. Patients who voluntarily agree to participate in this study and sign the informed consent form.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The pain relief rate of patients at the end of the 4-week treatment period
Timeframe: From enrollment to the end of treatment at 4 weeks.