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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Tours
NCT04937309 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * nausea or vomiting 24h or less, before inclusion * Antiemetic drug intake in the last 72h before inclusion * Central nervous system metastasis * Daily alcohol intake * Prior chemotherapy * Cardiac arrythmia, severe heart failure * Device for sleep apnea * History of arterial or venous thrombosis, or thrombophlebitis * Vagotomy * Vagal stimulation ongoing * Skin disease on the stimulation zone * Cochlear implant next to the stimulation zone * Unable to use the vagal stimulation device due to left ear unusual shape * Pregnant or breastfeeding women, or women of childbearing age without effective contraception * Documented allergy or contraindication to one of the antiemesis drugs required in the study * Protected adults (individuals under guardianship by court order) * Unable to read or write
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What it tests

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

8 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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