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.
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 with advanced breast cancer;
Patients with other significant organ dysfunction, such as major cardiovascular disease, diabetes mellitus, or hyperthyroidism;
Patients with other cancers;
Patients with a history of fracture or surgery around the painful joint area within the past 6 months;
Parallel
transcutaneous auricular vagus nerve stimulation
DeviceElectrodes 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.
sham stimulation
DeviceCompared 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.
The pain relief rate of patients at the end of the 4-week treatment period
Pain relief rate at follow-up
Dosage of analgesic drugs
Depression scores
PHQ-9 is used to measure depression. PHQ-9 ( unabbreviated scale title: Patient Health Questionnaire-9) Minimum Value: 0 Maximum Value: 27 Score Interpretation: Higher scores mean a WORSE outcome. Details:The PHQ-9 is a screening tool for depression. A higher score indicates more severe depressive symptoms. Generally, scores are interpreted as follows: 0-4 (Minimal), 5-9 (Mild), 10-14 (Moderate), 15-19 (Moderately Severe), and 20-27 (Severe) depression.
Anxiety scores
GAD-7 is used to measure anxiety. GAD-7 (unabbreviated scale title: Generalized Anxiety Disorder-7) Minimum Value: 0 Maximum Value: 21 Score Interpretation: Higher scores mean a WORSE outcome. Details:The GAD-7 measures the severity of generalized anxiety disorder. A higher score reflects more frequent and severe anxiety symptoms. Typical interpretations are: 0-4 (Minimal), 5-9 (Mild), 10-14 (Moderate), and 15-21 (Severe) anxiety.
Tumor marker levels
Adverse events and serious adverse events
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Peking University People's Hospital
Lead sponsor
National Natural Science Foundation of China
Collaborator
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