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Could a simple ear device ease chemo nausea without extra drugs?

NCT ID NCT04937309

Symptom relief Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a non-invasive device that gently stimulates a nerve in the ear can help prevent nausea caused by chemotherapy in breast cancer patients. Participants use the device twice daily around their chemo sessions, alongside standard anti-nausea medication. The goal is to see if adding this stimulation reduces nausea more than standard care alone or a sham device.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
non-invasive auricular vagal stimulation device
What this could lead to
If effective, this device could offer a drug-free way to reduce nausea during chemotherapy, improving quality of life for breast cancer patients.
What could go wrong
This is a mid-sized trial testing a device that may not outperform a sham (fake) device. Nausea is subjective, and results may not apply to other cancers or chemotherapies.

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 338 people

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

Started

Jun 2022

Expected to finish

Sep 2028

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

Anyone

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: * Eastern Cooperative Oncology Group (ECOG) status 0 to 2 * patient with breast cancer planned to receive Anthracycline and Cyclophosphamide chemotherapy * informed consent * compliance expected * social security affiliation Exclusion Criteria: * nausea or vomiting 24h or less, before inclusion * Antiemetic drug intake in the last 72h before inclusion * Central nervous system metastasis * Daily alcohol intake * Prior chemotherapy * Cardiac arrythmia, severe heart failure * Device for sleep apnea * History of arterial or venous thrombosis, or thrombophlebitis * Vagotomy * Vagal stimulation ongoing * Skin disease on the stimulation zone * Cochlear implant next to the stimulation zone * Unable to use the vagal stimulation device due to left ear unusual shape * Pregnant or breastfeeding women, or women of childbearing age without effective contraception * Documented allergy or contraindication to one of the antiemesis drugs required in the study * Protected adults (individuals under guardianship by court order) * Unable to read or write

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Nausea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CH BLOIS

    ACTIVE_NOT_RECRUITING

    Blois, France

  • CHRU Bretonneau

    RECRUITING

    Tours, France

  • CORT37

    RECRUITING

    Chambray-lès-Tours, France

  • Ch Chateauroux

    RECRUITING

    Châteauroux, France

  • Ch Chinon

    RECRUITING

    Saint-Benoît-la-Forêt, France

  • Ch Orleans

    ACTIVE_NOT_RECRUITING

    Orléans, France

  • Chru Morvan

    RECRUITING

    Brest, France

  • Clinique Victor Hugo

    RECRUITING

    Le Mans, France

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