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

Last updated: May 9, 2023
Sponsor: University Hospital, Tours
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Colic

Stomach Discomfort

Treatment

non invasive auricular vagal stimulation

sham stimulation

usual medical treatment

Clinical Study ID

NCT04937309
DR210090_SILENCE
  • Ages > 18
  • All Genders

Study 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.

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

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) status 0 to 2
  • patient with breast cancer planned to receive Anthracycline and Cyclophosphamidechemotherapy
  • informed consent
  • compliance expected
  • social security affiliation

Exclusion

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 effectivecontraception
  • Documented allergy or contraindication to one of the antiemesis drugs required in thestudy
  • Protected adults (individuals under guardianship by court order)
  • Unable to read or write

Study Design

Total Participants: 338
Treatment Group(s): 3
Primary Treatment: non invasive auricular vagal stimulation
Phase:
Study Start date:
June 24, 2022
Estimated Completion Date:
May 01, 2024

Study 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.

Connect with a study center

  • CH BLOIS

    Blois,
    France

    Site Not Available

  • Chru Morvan

    Brest,
    France

    Active - Recruiting

  • CORT37

    Chambray-lès-Tours,
    France

    Active - Recruiting

  • Ch Chateauroux

    Châteauroux,
    France

    Active - Recruiting

  • Clinique Victor Hugo

    Le Mans,
    France

    Active - Recruiting

  • Ch Orleans

    Orléans,
    France

    Site Not Available

  • Ch Chinon

    Saint-Benoît-la-Forêt,
    France

    Active - Recruiting

  • CHRU Bretonneau

    Tours,
    France

    Active - Recruiting

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