Ear zaps may soothe painful side effect of breast cancer drugs

NCT ID NCT07593365

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

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

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

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How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044, China

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