Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
Recruiting · NCT04937309 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
non invasive auricular vagal stimulationsham stimulationusual medical treatment
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
8 locations listed.
- 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