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Tests treatment safety and results for Breast Cancer
Official title Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
ClinicalTrials.gov ID: NCT04937309
What this study is testing
What is usual medical treatment?
usual medical treatment is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Blois, France
- Brest, France
- Chambray-lès-Tours, France
- Châteauroux, France
- Le Mans, France
- Orléans, France
- Saint-Benoît-la-Forêt, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blois, France; Brest, France; Chambray-lès-Tours, France; Châteauroux, France; Le Mans, France; Orléans, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.