Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

NCT ID: NCT05143554

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2025-09-23

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Auricular percutaneous neurostimulation

Intervention Type: DEVICE

Percutaneous neurostimulation

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)

Group Type: SHAM_COMPARATOR

Sham percutaneous neurostimulation

Intervention Type: DEVICE

Sham percutaneous neurostimulation

Interventions

Auricular percutaneous neurostimulation

Percutaneous neurostimulation

Intervention Type: DEVICE

Sham percutaneous neurostimulation

Sham percutaneous neurostimulation

Intervention Type: DEVICE

Other Intervention Names

IBStim

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Angela Steineck

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Wisconsin Hospital

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

1678523-2

Identifier Type: -

Identifier Source: org_study_id