Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea (NCT04937309) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
France338 participantsStarted 2022-06-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients with significant nausea after the first chemotherapy cycle