NCT04937309

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

Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (estimated)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	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
DRUG	usual medical treatment	Standard anti emetic treatments to prevent emesis due to chemotherapy
DEVICE	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

Timeline

• Start date: 2022-06-24
• Primary completion: 2024-02-15
• Completion: 2024-05-01
• First posted: 2021-06-24
• Last updated: 2023-05-11

Locations

8 sites across 1 country: France