Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy
University Hospital, Tours
338 participants
Jun 23, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria17
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles
Standard anti emetic treatments to prevent emesis due to chemotherapy
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04937309