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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
non invasive auricular vagal stimulation
usual medical treatment
sham stimulation
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring nausea, non invasive vagal stimulation, chemotherapy, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH BLOIS
  • Chru MorvanRecruiting
  • CORT37Recruiting
  • Ch ChateaurouxRecruiting
  • Clinique Victor HugoRecruiting
  • Ch Orleans
  • Ch ChinonRecruiting
  • CHRU BretonneauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

intervention

control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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
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
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
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
number and type of side effect during vagal stimulation safety
report of any side effect, based on patient declaration

Full Information

First Posted
June 3, 2021
Last Updated
May 9, 2023
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT04937309
Brief Title
Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea
Acronym
SILENCE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
nausea, non invasive vagal stimulation, chemotherapy, breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one control arm and one intervention arm
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
sham
Allocation
Randomized
Enrollment
338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
non invasive auricular vagal stimulation
Intervention Description
Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles
Intervention Type
Drug
Intervention Name(s)
usual medical treatment
Intervention Description
Standard anti emetic treatments to prevent emesis due to chemotherapy
Intervention Type
Device
Intervention Name(s)
sham stimulation
Intervention Description
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 Outcome Measure Information:
Title
Percentage of patients with significant nausea after the first chemotherapy cycle
Description
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.
Time Frame
2 to 3 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients with significant nausea after the second and the third chemotherapy cycle.
Description
Same measurement at the second and the third chemotherapy. And global score considering the three cycles together.
Time Frame
7 to 12 weeks
Title
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.
Description
Percentage of patients without any vomiting, or rescue emesis medication use, from first to third chemotherapy
Time Frame
7 to 12 weeks
Title
Percentage of non planned visit to emergency care unit or general practioner or oncologist due to emesis, measured for the three first chemotherapy cycles.
Description
To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle
Time Frame
7 to 12 weeks
Title
Percentage of non anticipated hydratation with IV fluids measured for the three first chemotherapy cycles.
Description
To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle
Time Frame
7 to 12 weeks
Title
Percentage of hospitalisations for emesis measured for the three first chemotherapy cycles.
Description
To measure complication due to emesis from the first cycle of chemotherapy to day 5 after the third chemotherapy cycle
Time Frame
7 to 12 weeks
Title
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
Description
patient reported outcome measure, using international validated questionnaires and patient diaries
Time Frame
9 to 15 weeks
Title
number and type of side effect during vagal stimulation safety
Description
report of any side effect, based on patient declaration
Time Frame
7 to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde CANCEL, MD
Phone
02 47 47 99 19
Email
m.cancel@chu-tours.fr
Facility Information:
Facility Name
CH BLOIS
City
Blois
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Chru Morvan
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura DEIANA
Email
laura.deiana@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Laura DEIANA
Facility Name
CORT37
City
Chambray-lès-Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tevy SAN
Email
t.san@cort37.fr
First Name & Middle Initial & Last Name & Degree
Tevy SAN
Facility Name
Ch Chateauroux
City
Châteauroux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François CHRISTIANN
Email
francois.christiann@ch-chateauroux.fr
First Name & Middle Initial & Last Name & Degree
François CHRISTIANN
Facility Name
Clinique Victor Hugo
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugues BOURGEOIS
Email
h.bourgeois@ilcgroupe.fr
First Name & Middle Initial & Last Name & Degree
Hugues BOURGEOIS
Facility Name
Ch Orleans
City
Orléans
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Ch Chinon
City
Saint-Benoît-la-Forêt
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion STACOFFE
Email
m.stacoffe@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Marion STACOFFE
Facility Name
CHRU Bretonneau
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde CANCEL, MD
Email
m.cancel@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Mathilde CANCEL, MD

12. IPD Sharing Statement

Learn more about this trial

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

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