Breast Cancer
Conditions
Keywords
nausea, non invasive vagal stimulation, chemotherapy, breast cancer
Brief 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.
Interventions
DEVICEnon invasive auricular vagal stimulation
Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles
DRUGusual medical treatment
Standard anti emetic treatments to prevent emesis due to chemotherapy
DEVICEsham 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
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
sham
Intervention model description
one control arm and one intervention arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with significant nausea after the first chemotherapy cycle | 2 to 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with significant nausea after the second and the third chemotherapy cycle. | 7 to 12 weeks | Same measurement at the second and the third chemotherapy. And global score considering the three cycles together. |
| 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. | 7 to 12 weeks | Percentage of patients without any vomiting, or rescue emesis medication use, from first to third chemotherapy |
| Percentage of non planned visit to emergency care unit or general practioner or oncologist due to emesis, measured for the three first chemotherapy cycles. | 7 to 12 weeks | To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle |
| Percentage of non anticipated hydratation with IV fluids measured for the three first chemotherapy cycles. | 7 to 12 weeks | To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle |
| Percentage of hospitalisations for emesis measured for the three first chemotherapy cycles. | 7 to 12 weeks | To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle |
| 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 | 9 to 15 weeks | patient reported outcome measure, using international validated questionnaires and patient diaries |
| number and type of side effect during vagal stimulation safety | 7 to 12 weeks | report of any side effect, based on patient declaration |
Countries
France
Contacts
CONTACTMathilde CANCEL, MD
Outcome results
None listed