Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

NCT05143554 | Terminated DMC FDA Device

• 1 other identifier: 1678523-2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Active percutaneous neurostimulation

ACTIVE COMPARATOR

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

Sham percutaneous neurostimulation

SHAM COMPARATOR

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

Interventions

Auricular percutaneous neurostimulation DEVICE

Percutaneous neurostimulation

Also known as: IBStim

Active percutaneous neurostimulation

Sham percutaneous neurostimulation DEVICE

Sham percutaneous neurostimulation

Sham percutaneous neurostimulation

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Wisconsin Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Each subject will be randomized to receive active vs sham therapy, then cross over to the other during the following cycle of chemotherapy

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: December 3, 2021
• Study Start: April 29, 2021
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)