Noninvasive vagal stimulation to help prevent chemotherapy-induced nausea in breast cancer
Official title: Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy
Run by University Hospital, Tours · NCT04937309 · Data updated 2026-11-12
This study tests whether a noninvasive vagal nerve stimulation device, used alongside standard anti-nausea medicines, can prevent nausea in breast cancer patients receiving certain chemotherapy drugs.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 338 (estimated) |
| Sponsor | University Hospital, Tours Academic / other |
| Drugs / interventions | chemotherapy, Cyclophosphamide |
| Locations | 8 sites (Blois and 7 other locations) |
| Status | Recruiting |
| Started | June 23, 2022 |
| Main results expected | July 30, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT04937309 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with breast cancer planned for anthracycline and cyclophosphamide chemotherapy, ECOG 0–2, and able to consent and comply with study requirements.
✕Probably not a fit
Patients with conditions or circumstances that interfere with vagal stimulation or antiemetic response, or those not responding to the added device, may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study investigates if adding noninvasive auricular vagal stimulation to standard antiemetic therapy reduces chemotherapy-induced nausea in breast cancer patients treated with cyclophosphamide and an anthracycline. The approach uses a wearable device to stimulate the ear’s vagal pathways and compares outcomes to a sham control. Eligible participants have breast cancer, an ECOG status of 0–2, and plan the specified chemotherapy, with exclusions including recent antiemetic use and certain medical conditions. The trial is conducted at multiple centers in France, led by University Hospital Tours.
Why it matters
Potential benefit: If successful, patients may experience less nausea during chemotherapy, improving quality of life and treatment adherence.
How similar studies have gone: Prior uses of noninvasive vagal stimulation in other conditions suggest potential antiemetic benefits, but evidence in chemotherapy-induced nausea is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Chru Morvan
Brest, France Recruiting -
Cort37
Chambray-lès-Tours, France Recruiting -
Ch Chateauroux
Châteauroux, France Recruiting -
Clinique Victor Hugo
Le Mans, France Recruiting -
Ch Chinon
Saint-Benoît-la-Forêt, France Recruiting -
CHRU Bretonneau
Tours, France Recruiting
Show 2 more locations
-
Ch Blois
Blois, France Active not recruiting -
Ch Orleans
Orléans, France Active not recruiting
Study contacts
- Study coordinator: Mathilde CANCEL, MD
- Email: m.cancel@chu-tours.fr
- Phone: 02 47 47 99 19
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.