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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular device. This stimulation is to be done for the three first cycles of chemotherapy. |
|
| control | Sham Comparator | standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular sham device. This "stimulation" is to be done for the three first cycles of chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non invasive auricular vagal stimulation | Device | Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathilde CANCEL, MD | Contact | 02 47 47 99 19 | m.cancel@chu-tours.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH BLOIS | Active, not recruiting | Blois | France | |||
| Chru Morvan |
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one control arm and one intervention arm
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sham
| usual medical treatment | Drug | Standard anti emetic treatments to prevent emesis due to chemotherapy |
|
| sham stimulation | Device | Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles, with a sham device |
|
Percentage of patients without any vomiting, or rescue emesis medication use, from first to third chemotherapy |
| 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 | 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 | 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 | 7 to 12 weeks |
| 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 |
| number and type of side effect during vagal stimulation safety | report of any side effect, based on patient declaration | 7 to 12 weeks |
| Recruiting |
| Brest |
| France |
|
| CORT37 | Recruiting | Chambray-lès-Tours | France |
|
| Ch Chateauroux | Recruiting | Châteauroux | France |
|
| Clinique Victor Hugo | Recruiting | Le Mans | France |
|
| Ch Orleans | Active, not recruiting | Orléans | France |
| Ch Chinon | Recruiting | Saint-Benoît-la-Forêt | France |
|
| CHRU Bretonneau | Recruiting | Tours | France |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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