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NCT Number: NCT04937309

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Nausea Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH BLOIS, Blois, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of patients with significant nausea after the second and the third chemotherapy cycle.

    Time frame: 7 to 12 weeks

    Same measurement at the second and the third chemotherapy. And global score considering the three cycles together.

  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.

    Time frame: 7 to 12 weeks

    Percentage of patients without any vomiting, or rescue emesis medication use, from first to third chemotherapy

  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.

    Time frame: 7 to 12 weeks

    To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle

  4. Percentage of non anticipated hydratation with IV fluids measured for the three first chemotherapy cycles.

    Time frame: 7 to 12 weeks

    To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle

  5. Percentage of hospitalisations for emesis measured for the three first chemotherapy cycles.

    Time frame: 7 to 12 weeks

    To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle

  6. 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

    patient reported outcome measure, using international validated questionnaires and patient diaries

  7. number and type of side effect during vagal stimulation safety

    Time frame: 7 to 12 weeks

    report of any side effect, based on patient declaration

Study contacts

Contact information is provided by the study sponsor or research team.

Mathilde CANCEL, MD

CONTACT

[email protected]

02 47 47 99 19

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy

Acronym: SILENCE

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2021
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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