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

Breast Cancer Clinical Trial

— SILENCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937309
• Other study ID #: DR210090_SILENCE
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Tours
• Contact: Mathilde CANCEL, MD
• Phone: 02 47 47 99 19
• Email: m.cancel[@]chu-tours.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: May 1, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Nausea

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with significant nausea after the first chemotherapy cycle	Nausea severity is graded daily from Day 1 (day of chemotherapy) to Day 5, using a numeric scale from 0 to 10. It is a patient reported outcome, patients using a diary. Significant nausea is a score of 2 or more.	2 to 3 weeks
Secondary	Percentage of patients with significant nausea after the second and the third chemotherapy cycle.	Same measurement at the second and the third chemotherapy. And global score considering the three cycles together.	7 to 12 weeks
Secondary	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.	Percentage of patients without any vomiting, or rescue emesis medication use, from first to third chemotherapy	7 to 12 weeks
Secondary	Percentage of non planned visit to emergency care unit or general practioner or oncologist due to emesis, measured for the three first chemotherapy cycles.	To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle	7 to 12 weeks
Secondary	Percentage of non anticipated hydratation with IV fluids measured for the three first chemotherapy cycles.	To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle	7 to 12 weeks
Secondary	Percentage of hospitalisations for emesis measured for the three first chemotherapy cycles.	To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle	7 to 12 weeks
Secondary	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	patient reported outcome measure, using international validated questionnaires and patient diaries	9 to 15 weeks
Secondary	number and type of side effect during vagal stimulation safety	report of any side effect, based on patient declaration	7 to 12 weeks