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

Sponsor
University Hospital, Tours (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04937309
Collaborator
(none)
338
2
23

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: non invasive auricular vagal stimulation
  • Drug: usual medical treatment
  • Device: sham stimulation
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
338 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
one control arm and one intervention armone control arm and one intervention arm
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
sham
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Feb 15, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention

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.

Device: non invasive auricular vagal stimulation
Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles

Drug: usual medical treatment
Standard anti emetic treatments to prevent emesis due to chemotherapy

Sham Comparator: control

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.

Drug: usual medical treatment
Standard anti emetic treatments to prevent emesis due to chemotherapy

Device: sham stimulation
Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles, with a sham device

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients with significant nausea after the first chemotherapy cycle [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 Outcome Measures

  1. Percentage of patients with significant nausea after the second and the third chemotherapy cycle. [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. [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. [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. [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. [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 [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 [7 to 12 weeks]

    report of any side effect, based on patient declaration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT04937309
Other Study ID Numbers:
  • DR210090_SILENCE
First Posted:
Jun 24, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Tours
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022