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

NCT04937309 | Unknown

• 1 other identifier: DR210090_SILENCE
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 8

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.

Conditions

Breast Cancer

Keywords

nausea; non invasive vagal stimulation; chemotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 to 3 weeks

Secondary Outcomes (7)

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

  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.

  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.

  7 to 12 weeks

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

  7 to 12 weeks

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

  7 to 12 weeks

Study Arms (2)

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.

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.

Drug: usual medical treatment; Device: sham stimulation

Interventions

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

intervention

usual medical treatment DRUG

Standard anti emetic treatments to prevent emesis due to chemotherapy

control; intervention

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

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (8)

CH BLOIS

Blois, France

ACTIVE NOT RECRUITING

Chru Morvan

Brest, France

RECRUITING

CORT37

Chambray-lès-Tours, France

RECRUITING

Ch Chateauroux

Châteauroux, France

RECRUITING

Clinique Victor Hugo

Le Mans, France

RECRUITING

Ch Orleans

Orléans, France

ACTIVE NOT RECRUITING

Ch Chinon

Saint-Benoît-la-Forêt, France

RECRUITING

CHRU Bretonneau

Tours, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Nausea

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mathilde CANCEL, MD

CONTACT

02 47 47 99 19; m.cancel@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: sham
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one control arm and one intervention arm

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 24, 2021
• Study Start: June 24, 2022
• Primary Completion: February 15, 2024
• Study Completion: May 1, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

FR (8)