Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting
Primary Purpose
Chemotherapy-induced Nausea and Vomiting
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular percutaneous neurostimulation
Sham percutaneous neurostimulation
Sponsored by
About this trial
This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting
Eligibility Criteria
Inclusion Criteria:
- Subjects who are scheduled to be admitted for chemotherapy administration and who will have at least one additional cycle of the same chemotherapy
- Chemotherapy regimens must include moderate and/or severe emetogenic chemotherapy
Exclusion Criteria:
- Significant developmental delays that would prohibit participation
- Infection or severe dermatological condition of ear
- Uncontrolled or severe infection
- No implanted electrical device is permitted
- Pregnancy
- Severe cardiopulmonary disease
- Diagnosis of hemophilia or other bleeding disorders
- Diagnosis psoriasis vulgaris
Sites / Locations
- Children's Wisconsin HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active percutaneous neurostimulation
Sham percutaneous neurostimulation
Arm Description
Subject randomized to maximum of 5 days of active vs sham neurostimulation therapy with moderate to severe emetogenic chemotherapy admission . With the next scheduled identical chemotherapy cycle, each subject will cross over to the other one (active vs sham)
Subject randomized to maximum of 5 days of active vs sham neurostimulation therapy with moderate to severe emetogenic chemotherapy admission . With the next scheduled identical chemotherapy cycle, each subject will cross over to the other one (active vs sham)
Outcomes
Primary Outcome Measures
Baxter Retching Faces Scale
Nausea severity assessed by pictorial nausea faces scale 0-10 (0=no nausea; 10= worse possible nausea) multiple times during hospitalization until discharge
Change in Rhodes Index of Nausea, Vomiting and Retching (INVR)
Short 8 item questionnaire to assess severity of nausea, vomiting and retching symptoms
Assessment of Rescue Medication
Number of rescue medications to be assessed on daily basis.
Secondary Outcome Measures
Full Information
NCT ID
NCT05143554
First Posted
July 6, 2021
Last Updated
September 26, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT05143554
Brief Title
Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting
Official Title
Efficacy of Auricular Neurostimulation for Children Adolescents and Young Adults With Chemotherapy Induced Nausea and Vomiting
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
April 29, 2025 (Anticipated)
Study Completion Date
April 29, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the efficacy of auricular percutaneous electrical nerve field stimulator in children, adolescents and young adults with chemotherapy induced nausea and vomiting.
Detailed Description
Chemotherapy induced nausea and vomiting (CINV) is a difficult to treat and potentially debilitating complication of chemotherapy. Nausea and vomiting are one of the most prevalent and problematic side effects associated with chemotherapy treatment, effecting numerous patients.
Autonomic nervous system (ANS) and the vagus nerve are important modulators of nausea and vomiting and are responsible for conveying visceral sensory information to the central nervous system responsible for nausea and vomiting. The aim of the study is to determine if stimulating a branch of the vagus nerve in the outer ear would reduce the frequency and severity of nausea and vomiting for patients undergoing chemotherapy treatment.
Subjects will be randomized to receive active vs sham (non-active) neurostimulation therapy which would be applied for maximum of 5 days at the onset of inpatient admission for moderate to severe emetogenic chemotherapy cycle. They will then cross over to the other group (active vs sham) during the admission of the following identical chemotherapy cycle. Nausea, vomiting, the need for additional antiemetic support and potential side effects will be monitored during the entire study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each subject will be randomized to receive active vs sham therapy, then cross over to the other during the following cycle of chemotherapy
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active percutaneous neurostimulation
Arm Type
Active Comparator
Arm Description
Subject randomized to maximum of 5 days of active vs sham neurostimulation therapy with moderate to severe emetogenic chemotherapy admission . With the next scheduled identical chemotherapy cycle, each subject will cross over to the other one (active vs sham)
Arm Title
Sham percutaneous neurostimulation
Arm Type
Sham Comparator
Arm Description
Subject randomized to maximum of 5 days of active vs sham neurostimulation therapy with moderate to severe emetogenic chemotherapy admission . With the next scheduled identical chemotherapy cycle, each subject will cross over to the other one (active vs sham)
Intervention Type
Device
Intervention Name(s)
Auricular percutaneous neurostimulation
Other Intervention Name(s)
IBStim
Intervention Description
Percutaneous neurostimulation
Intervention Type
Device
Intervention Name(s)
Sham percutaneous neurostimulation
Intervention Description
Sham percutaneous neurostimulation
Primary Outcome Measure Information:
Title
Baxter Retching Faces Scale
Description
Nausea severity assessed by pictorial nausea faces scale 0-10 (0=no nausea; 10= worse possible nausea) multiple times during hospitalization until discharge
Time Frame
From the date of baseline assessment up to 7 days after completion of intervention ( day 13)
Title
Change in Rhodes Index of Nausea, Vomiting and Retching (INVR)
Description
Short 8 item questionnaire to assess severity of nausea, vomiting and retching symptoms
Time Frame
From the date of baseline assessment and during the intervention (up to day 5)
Title
Assessment of Rescue Medication
Description
Number of rescue medications to be assessed on daily basis.
Time Frame
From the date of baseline assessment up to 7 days after completion of intervention ~ day 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who are scheduled to be admitted for chemotherapy administration and who will have at least one additional cycle of the same chemotherapy
Chemotherapy regimens must include moderate and/or severe emetogenic chemotherapy
Exclusion Criteria:
Significant developmental delays that would prohibit participation
Infection or severe dermatological condition of ear
Uncontrolled or severe infection
No implanted electrical device is permitted
Pregnancy
Severe cardiopulmonary disease
Diagnosis of hemophilia or other bleeding disorders
Diagnosis psoriasis vulgaris
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Harker-Murray, MD
Phone
414-955-4108
Email
pharker@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Steineck, MD
Phone
414-955-4108
Email
asteineck@mcw.edu
Facility Information:
Facility Name
Children's Wisconsin Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Steineck, MD
Phone
414-955-4108
Email
asteineck@mcw.edu
First Name & Middle Initial & Last Name & Degree
Paul Harker-Murray, MD
Phone
414-955-4108
Email
pharker@mcw.edu
12. IPD Sharing Statement
Learn more about this trial
Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting
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