Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Auricular Neurostimulation for Children Adolescents and Young Adults With Chemotherapy Induced Nausea and Vomiting

Conditions
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Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Device: Auricular percutaneous neurostimulation
* Device: Sham percutaneous neurostimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active percutaneous neurostimulation<br>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) | Device: Auricular percutaneous neurostimulation<br>* Percutaneous neurostimulation<br>* Other names: IBStim;|
| Sham Comparator: Sham percutaneous neurostimulation<br>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) | Device: Sham percutaneous neurostimulation<br>* Sham percutaneous neurostimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From the date of baseline assessment up to 7 days after completion of intervention ( day 13) | 
| Change in Rhodes Index of Nausea, Vomiting and Retching (INVR) | Short 8 item questionnaire to assess severity of nausea, vomiting and retching symptoms | From the date of baseline assessment and during the intervention (up to day 5) | 
| Assessment of Rescue Medication | Number of rescue medications to be assessed on daily basis. | From the date of baseline assessment up to 7 days after completion of intervention   day 13 |