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RECRUITING
NCT04937309
NA

Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

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

DEVICE

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

DRUG

usual medical treatment

Standard anti emetic treatments to prevent emesis due to chemotherapy

DEVICE

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