Ear zaps may soothe painful side effect of breast cancer drugs
NCT ID NCT07593365
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a gentle electrical stimulation on the ear (called taVNS) can reduce joint and muscle pain caused by aromatase inhibitors, a common breast cancer treatment. 216 women with hormone-positive breast cancer will receive either real or sham stimulation daily for 28 days. Researchers will track pain levels, mood, quality of life, and side effects over 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous auricular vagus nerve stimulation (taVNS)
- What this could lead to
- If it works, this could offer a non-drug way to reduce pain and improve quality of life for breast cancer patients on hormone therapy.
- What could go wrong
- This is an early-stage trial with a sham control, so results may not be conclusive. The treatment is daily for 28 days, and benefits may not last or apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female participants aged over 18 years; 2. Patients with pathologically confirmed stage I-III primary breast cancer; 3. Patients who have recovered from systemic symptoms related to surgery, radiotherapy, or chemotherapy; 4. 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); 5. Patients who have received aromatase inhibitor therapy for more than 30 days and are expected to continue treatment for more than 1 year; 6. Patients who voluntarily agree to participate in this study and sign the informed consent form. For participants receiving combined IL-2 treatment, the following additional criterion applies: 7. Pain relief rate of less than 50% after taVNS treatment and a lower peripheral blood Treg count than before treatment. Exclusion Criteria: 1. Patients with advanced breast cancer; 2. Patients with other significant organ dysfunction, such as major cardiovascular disease, diabetes mellitus, or hyperthyroidism; 3. Patients with other cancers; 4. Patients with a history of fracture or surgery around the painful joint area within the past 6 months; 5. Patients currently receiving corticosteroids or opioid therapy; 6. Patients with contraindications to vagus nerve stimulation; 7. Patients who are unable to communicate normally, such as those with cognitive impairment or hearing impairment; 8. Patients who have participated in another clinical trial within the past 1 month. For participants receiving combined IL-2 treatment, the following additional exclusion criteria apply: 9. Severe cardiac or renal disease, or hematologic disease; 10. Previous IL-2-related toxic reaction or allergy; 11. Use of other biologic agents or immunosuppressive drugs within the past 1 month; 12. Any other condition that the investigator considers unsuitable for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
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Other studies related to the condition(s) this trial covers.
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