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

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: non invasive auricular vagal stimulation; Device: sham stimulation; Drug: usual medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04937309

DR210090_SILENCE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 338 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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338 participants in 2 patient groups

intervention

Experimental group

Description:

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.

Treatment:

Drug: usual medical treatment

Device: non invasive auricular vagal stimulation

control

Sham Comparator group

Description:

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.

Treatment:

Drug: usual medical treatment

Device: sham stimulation