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Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
Sponsor: University Hospital, Tours
Summary
Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life. Non invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea. This study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
338
Start Date
2022-06-23
Completion Date
2028-09-30
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
non invasive auricular vagal stimulation
Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles
usual medical treatment
Standard anti emetic treatments to prevent emesis due to chemotherapy
sham stimulation
Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles, with a sham device
Locations (8)
CH BLOIS
Blois, France
Chru Morvan
Brest, France
CORT37
Chambray-lès-Tours, France
Ch Chateauroux
Châteauroux, France
Clinique Victor Hugo
Le Mans, France
Ch Orleans
Orléans, France
Ch Chinon
Saint-Benoît-la-Forêt, France
CHRU Bretonneau
Tours, France