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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

usual medical treatment: Standard anti emetic treatments to prevent emesis due to chemotherapy

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

Study 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

Primary outcome measure(s)

• Percentage of patients with significant nausea after the first chemotherapy cycle — 2 to 3 weeks
  Nausea severity is graded daily from Day 1 (day of chemotherapy) to Day 5, using a numeric scale from 0 to 10. It is a patient reported outcome, patients using a diary. Significant nausea is a score of 2 or more.

Trial sites (8)

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