Health TrialsbyHealthPanel

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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) status 0 to 2

patient with breast cancer planned to receive Anthracycline and Cyclophosphamide chemotherapy

informed consent

compliance expected

Disqualifiers

nausea or vomiting 24h or less, before inclusion

Antiemetic drug intake in the last 72h before inclusion

Central nervous system metastasis

Daily alcohol intake

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

338 Participants
are divided into 2 treatment groups
Group A: interventionExperimental treatment 2 interventions
Group B: controlSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Tours

Lead sponsor

Source ClinicalTrials.gov
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