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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

About this trial

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 criteria

Qualifiers

Eastern Cooperative Oncology Group (ECOG) status 0 to 2

patient with breast cancer planned to receive Anthracycline and Cyclophosphamide chemotherapy

informed consent

compliance expected

Disqualifiers

nausea or vomiting 24h or less, before inclusion

Antiemetic drug intake in the last 72h before inclusion

Central nervous system metastasis

Daily alcohol intake

Trial design

Treatments tested in this trial

  • non invasive auricular vagal stimulation
  • usual medical treatment
  • sham stimulation

Treatment groups

338 Participants
are divided into 2 treatment groups

Sponsors and collaborators