Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CH BLOIS
ACTIVE_NOT_RECRUITING
Blois
Chru Morvan
RECRUITING
Brest
CORT37
RECRUITING
Chambray-lès-tours
Ch Chateauroux
RECRUITING
Châteauroux
Clinique Victor Hugo
RECRUITING
Le Mans
Ch Orleans
ACTIVE_NOT_RECRUITING
Orléans
Ch Chinon
RECRUITING
Saint-benoît-la-forêt
CHRU Bretonneau
RECRUITING
Tours
Contact Information
Primary
Mathilde CANCEL, MD
m.cancel@chu-tours.fr
02 47 47 99 19
Time Frame
Start Date: 2022-06-23
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 338
Treatments
Experimental: intervention
standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular device. This stimulation is to be done for the three first cycles of chemotherapy.
Sham_comparator: control
standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular sham device. This stimulation is to be done for the three first cycles of chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Tours