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

Study acronym: SILENCE
StatusRecruiting
PhaseNot applicable
Started2022-06-23
View on ClinicalTrials.gov ↗

Amendment history

2026-06-16
Study Status v4
Primary completion date2024-02-15→2028-07-30
Completion date2024-05-01→2028-09-30
Start date2022-06-24→2022-06-23
2023-05-09
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-06-01→confirmed 2022-06-24
2022-05-17
Study Status v2
Start date2022-02-03→2022-06-01
2021-10-13
Study Status v1
Primary completion date2023-06-15→2024-02-15
Completion date2023-08-01→2024-05-01
Start date2021-07-03→2022-02-03
2021-06-21
Original filing
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.
Trial Details
NCT Number NCT04937309
Lead Sponsor University Hospital, Tours
Conditions Breast Cancer
Enrollment 338 participants
Start Date 2022-06-23
Primary Completion 2028-07-30 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-17