MedTrace Logo

Clinical Application of Vagus Nerve Stimulation Combined With Immunoregulatory T Cells in Alleviating Aromatase Inhibitor-Induced Pain

NCT07593365 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)
  • Breast Cancer
  • Pain Alleviation

Interventions

DEVICE

transcutaneous auricular vagus nerve stimulation

Electrodes will be placed on specific areas of the participant's left external ear that are mainly innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days.

DEVICE

sham stimulation

Compared with transcutaneous auricular vagus nerve stimulation group, electrodes will be placed on different areas of the participant's left external ear that are not innervated by the auricular branch of the vagus nerve. The electrodes will be connected to an electrical stimulation device, and stimulation will be delivered at tolerable intensity using preset study parameters. Treatment will be given once daily for 28 consecutive days.

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07593365 on ClinicalTrials.gov