Breast CancerSILENCENCT04937309
Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
A study testing non invasive auricular vagal stimulation and usual medical treatment in people with Breast Cancer, run by University Hospital, Tours at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- non invasive auricular vagal stimulation and usual medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- 8 sitesFrance
- Study dates
- 23 Jun 2022to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 6 recruiting
- Active, not recruiting
CH BLOIS
Blois
- Recruiting
Chru Morvan
Brest
Laura DEIANA, laura.deiana@chu-brest.fr
Laura DEIANA
- Recruiting
CORT37
Chambray-lès-Tours
Tevy SAN, t.san@cort37.fr
Tevy SAN
- Recruiting
Ch Chateauroux
Châteauroux
François CHRISTIANN, francois.christiann@ch-chateauroux.fr
François CHRISTIANN
- Recruiting
Clinique Victor Hugo
Le Mans
Hugues BOURGEOIS, h.bourgeois@ilcgroupe.fr
Hugues BOURGEOIS
- Active, not recruiting
Ch Orleans
Orléans
- Recruiting
Ch Chinon
Saint-Benoît-la-Forêt
Marion STACOFFE, m.stacoffe@chu-tours.fr
Marion STACOFFE
- Recruiting
CHRU Bretonneau
Tours
Mathilde CANCEL, MD, m.cancel@chu-tours.fr
Mathilde CANCEL, MD
About this study
Official title: Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- non invasive auricular vagal stimulation, usual medical treatment, sham stimulation
- Keywords
- nausea, non invasive vagal stimulation, chemotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: non invasive auricular vagal stimulation; Drug: usual medical treatment |
| 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. Receives: Drug: usual medical treatment; Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 to 3 weeks
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 9 to 15 weeks
number and type of side effect during vagal stimulation safety
report of any side effect, based on patient declaration
Measured: 7 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start23 Jun 2022
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- one control arm and one intervention arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937309
- Sponsor's protocol ID
- DR210090_SILENCE
- Acronym
- SILENCE
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2021
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy
- ClinicalTrials.gov ID
- NCT04937309
- Acronym / sponsor ID
- SILENCE / DR210090_SILENCE
- Conditions
- Breast Cancer
- Keywords
- nausea, non invasive vagal stimulation, chemotherapy, breast cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one control arm and one intervention arm
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: non invasive auricular vagal stimulation, Drug: usual medical treatmentstandard 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 | Drug: usual medical treatment, Device: sham stimulationstandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non invasive auricular vagal stimulationStimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles | Device | intervention |
| usual medical treatmentStandard anti emetic treatments to prevent emesis due to chemotherapy | Drug | control, intervention |
| sham stimulationStimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles, with a sham device | Device | control |
Primary outcome
Percentage of patients with significant nausea after the first chemotherapy cycle
Time frame: 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.
7 secondary outcomes
Percentage of patients with significant nausea after the second and the third chemotherapy cycle.
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.
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.
Time frame: 7 to 12 weeks
Percentage of non anticipated hydratation with IV fluids measured for the three first chemotherapy cycles.
Time frame: 7 to 12 weeks
Percentage of hospitalisations for emesis measured for the three first chemotherapy cycles.
Time frame: 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
Time frame: 9 to 15 weeks
number and type of side effect during vagal stimulation safety
Time frame: 7 to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non invasive auricular vagal stimulation and usual medical treatment in people with Breast Cancer, run by University Hospital, Tours at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde CANCEL, MD (02 47 47 99 19, m.cancel@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with significant nausea after the first chemotherapy cycle (time frame: 2 to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.