Could a tiny ear device ease joint pain in breast cancer survivors?
NCT ID NCT07575750
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a small, wearable device that gently stimulates a nerve in the ear to reduce joint pain and stiffness caused by common breast cancer hormone pills (aromatase inhibitors). About 60 women with breast cancer who have joint pain will use either the active device or a sham device for 6 weeks. The goal is to see if this non-invasive approach can safely ease pain and improve quality of life.
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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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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. Menopausal women receiving an aromatase inhibitor (AI) as adjuvant treatment for breast cancer (letrozole (Femara), anastrozole (Arimidex) or exemestane (Aromasin)). The same AI must have been the same during the 4 weeks preceding inclusion and not be intended to be changed during the study period; 2. Polyarticular and symmetrical pain that developed or worsened after the initiation of AI therapy and has persisted for at least 1 month; 3. Score greater than 4 within 7 days before randomization (range,0-10; higher scores indicate greater pain) on the average pain item of the Brief Pain Inventory-Short Form (BPI-SF) as reported by patient; 4. Patients receiving stable background analgesic treatment for AIA may be included, provided that this treatment has remained stable and that no new medication has been initiated prior to inclusion, as follows: * Analgesic treatment: stable for at least 2 weeks before inclusion, with no initiation of new medication. * Antidepressant treatment, including serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine, venlafaxine): stable for at least 4 weeks before inclusion, with no initiation of new medication." 5. Patients with an Eastern Cooperative Oncology Group performance status of 0 to 2; 6. Patient covered by a social security system; 7. Patient mastering the French language and able to complete the evaluation questionnaires; 8. Signed written informed consent form. Exclusion Criteria: 1. Patients who have previously used an electrostimulation device for pain management; 2. Use of vagus nerve stimulation prior to the study; 3. Patients who have received auriculotherapy for the same indication within the previous 4 weeks or who plan to initiate such treatment during the study; 4. Symptomatic orthostatic hypotension (according to investigator) or recurrent vasovagal syncope or history of vagotomy; 5. Previously implanted electrically active medical devices (eg, cardiac pacemakers or automatic implantable cardioverter defibrillators), or significant electrocardiogram abnormalities (cardiac rhythm disturbances, atrioventricular block \>first degree or total bundle branch block); 6. Current treatment with beta-blocker drugs; 7. Patient under guardianship or unable to give informed consent; 8. Patient unable to undergo medical follow-up for geographical, social or psychopathological reasons.
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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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Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
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Other studies related to the condition(s) this trial covers.
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- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?