Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
NCT ID: NCT04937309
Last Updated: 2023-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
338 participants
INTERVENTIONAL
2022-06-24
2024-05-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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intervention
standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular device. This stimulation is to be done for the three first cycles of chemotherapy.
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
control
standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular sham device. This "stimulation" is to be done for the three first cycles of chemotherapy.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* patient with breast cancer planned to receive Anthracycline and Cyclophosphamide chemotherapy
* informed consent
* compliance expected
* social security affiliation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DR210090_SILENCE
Identifier Type: -
Identifier Source: org_study_id
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