Non-Invasive Vagal Stimulation to Reduce Chemotherapy-Induced Nausea in Breast Cancer Patients Receiving Anthracycline and Cyclophosphamide

What this Trial Is About

This research evaluates whether non-invasive vagal stimulation can better prevent chemotherapy-induced nausea in breast cancer patients undergoing cyclophosphamide and anthracycline treatment. Chemotherapy-induced nausea remains common and negatively impacts quality of life despite existing medications. Non-invasive vagal stimulation is approved for other conditions like headache and gastroparesis and may reduce nausea. Participants receive standard antiemetic treatment along with either active non-invasive auricular vagal stimulation or a sham stimulation twice daily, starting the day before chemotherapy until four days after, during the first three chemotherapy cycles. The stimulation uses a transcutaneous auricular device to assess if adding this method improves nausea control compared to standard care alone. Throughout the study, participants are monitored for nausea occurrence after each chemotherapy cycle, vomiting, use of rescue medications, emergency visits, hydration needs, and hospitalizations related to nausea. Quality of life questionnaires specific to breast cancer and general health are completed during the first three cycles. Safety and side effects related to vagal stimulation are also evaluated. The trial measures outcomes over up to 12 weeks, with primary focus on nausea after the first chemotherapy cycle.

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