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Ear stimulation device aims to ease chemo side effects in ovarian cancer

NCT ID NCT06817161

Symptom relief Sponsor: Centre Francois Baclesse 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 improve quality of life by reducing digestive symptoms like nausea and bloating during first-line chemotherapy for ovarian cancer. About 116 women will be randomly assigned to receive either real or sham stimulation alongside their standard treatment. The goal is to see if this simple, drug-free approach can help patients feel better during chemotherapy.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 116 people

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

Started

Apr 2025

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

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: * Patient ≥ 18 years old * ECOG 0-2 * Histologically proven epithelial ovarian carcinoma * FIGO stage ≥ IIB * Patient candidate for first line chemotherapy treatment (alone, neoadjuvant or adjuvant) * Patient affiliated to an appropriate social security system * Patient who has signed informed consent obtained before any trial related activities Exclusion Criteria: * Patient with an active implantable medical device or any other implanted electronic or electrical device (pacemaker, defibrillator, etc.) * Dermatological problems in the area where stimulation electrodes are applied * Recent history (\<2 years) of epileptic seizures * Proven severe cardiovascular disease (such as known FEV \<40%, severe valvulpathy…) or HRV analysis not possible (such as uncontrolled atrial fibrillation) * Serious ear pathology * Documented vegetative neuropathy * Unusual morphology of the left ear which does not allow the use of the device * Patient with a cochlear implant near to the stimulation site * Impaired cognitive abilities * Concurrent other malignancy (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma) * Pregnant or breastfeeding woman * Simultaneous participation in another clinical study that may compromise the conduct of this study. * Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol * Patient deprived of liberty or placed under the authority of a tutor

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Conditions

The condition(s) this trial relates to.

Digestive System Diseases digestive system disorder ovarian cancer ovarian carcinoma

As listed by the trial registrant

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

Digestive system disorders First line chemotherapy Ovarian carcinoma

How to take part

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

  1. The places running it

    4 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

  • CHU CAEN

    NOT_YET_RECRUITING

    Caen, France

  • Centre François Baclesse

    RECRUITING

    Caen, France

  • Centre Henri Becquerel

    NOT_YET_RECRUITING

    Rouen, France

  • Centre Oscar Lambret

    NOT_YET_RECRUITING

    Lille, France

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