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

University Hospital, Tours338 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

338

Conditions

Breast Cancer

Interventions

non invasive auricular vagal stimulationDEVICE

Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles

usual medical treatmentDRUG

Standard anti emetic treatments to prevent emesis due to chemotherapy

sham stimulationDEVICE

Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles, with a sham device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

CH BLOIS

Blois, France

ACTIVE_NOT_RECRUITING

Chru Morvan

Brest, France

RECRUITING

CORT37

Chambray-lès-Tours, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 2 to 3 weeks

Secondary Outcomes

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.

Time frame: 7 to 12 weeks

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

Time frame: 7 to 12 weeks

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

Time frame: 7 to 12 weeks

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

Time frame: 7 to 12 weeks

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

Central Contacts

Mathilde CANCEL, MD

CONTACT

02 47 47 99 19 m.cancel@chu-tours.fr

Data from ClinicalTrials.gov

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