Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

Last updated: November 25, 2024
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stomach Discomfort

Lactose Intolerance

Vomiting

Treatment

Sham percutaneous neurostimulation

Auricular percutaneous neurostimulation

Clinical Study ID

NCT05143554
1678523-2
  • Ages 4-30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects who are scheduled to be admitted for chemotherapy administration and whowill have at least one additional cycle of the same chemotherapy

  • Chemotherapy regimens must include moderate and/or severe emetogenic chemotherapy

Exclusion

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 Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Sham percutaneous neurostimulation
Phase:
Study Start date:
April 29, 2021
Estimated Completion Date:
April 29, 2025

Study 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.

Connect with a study center

  • Children's Wisconsin Hospital

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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