Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

September 23, 2025 updated by: Angela Steineck, Medical College of Wisconsin

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

This study evaluates the efficacy of auricular percutaneous electrical nerve field stimulator in children, adolescents and young adults with chemotherapy induced nausea and vomiting.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Wisconsin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active percutaneous neurostimulation
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
Percutaneous neurostimulation
Other Names:
  • IBStim
Sham Comparator: Sham percutaneous neurostimulation
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
Sham percutaneous neurostimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baxter Retching Faces Scale
Time Frame: From the date of baseline assessment up to 7 days after completion of intervention ( day 13)
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)
Time Frame: From the date of baseline assessment and during the intervention (up to day 5)
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
Time Frame: From the date of baseline assessment up to 7 days after completion of intervention ~ day 13
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Actual)

September 23, 2025

Study Completion (Actual)

September 23, 2025

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1678523-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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