Clinical trial NCT04937309: Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
Official title: Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: nausea
non invasive vagal stimulation
chemotherapy
breast cancer
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one control arm and one intervention arm
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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: 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

Primary outcomes:
measure: Percentage of patients with significant nausea after the first chemotherapy cycle
timeFrame: 2 to 3 weeks
Secondary outcomes:
measure: Percentage of patients with significant nausea after the second and the third chemotherapy cycle.
timeFrame: 7 to 12 weeks
measure: Percentage of patients that did not vomit or use rescue emesis medication, from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle.
timeFrame: 7 to 12 weeks
measure: Percentage of non planned visit to emergency care unit or general practioner or oncologist due to emesis, measured for the three first chemotherapy cycles.
timeFrame: 7 to 12 weeks
measure: Percentage of non anticipated hydratation with IV fluids measured for the three first chemotherapy cycles.
timeFrame: 7 to 12 weeks
measure: Percentage of hospitalisations for emesis measured for the three first chemotherapy cycles.
timeFrame: 7 to 12 weeks
measure: quality of life measurement using international validated questionnaire EORTC QLQ-C30 (quality of life questionnaire -C30), EORTC QLQ-BR23 (quality of life questionnaire for breast cancer), completed at the first three cycles
timeFrame: 9 to 15 weeks
measure: number and type of side effect during vagal stimulation safety
timeFrame: 7 to 12 weeks
Other outcomes:
Locations:
city: Blois
country: France
facility: CH BLOIS
city: Brest
country: France
facility: Chru Morvan
city: Chambray-lès-Tours
country: France
facility: CORT37
city: Châteauroux
country: France
facility: Ch Chateauroux
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Orléans
country: France
facility: Ch Orleans
city: Saint-Benoît-la-Forêt
country: France
facility: Ch Chinon
city: Tours
country: France
facility: CHRU Bretonneau
Study officials:
References: