Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143554
• Other study ID #: 1678523-2
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: April 29, 2025

Study information

• Verified date: September 2023
• Source: Medical College of Wisconsin
• Contact: Paul Harker-Murray, MD
• Phone: 414-955-4108
• Email: pharker[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 29, 2025
• Est. primary completion date: April 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Device:
• Auricular percutaneous neurostimulation
Percutaneous neurostimulation
• Sham percutaneous neurostimulation
Sham percutaneous neurostimulation

Locations

Country	Name	City	State
United States	Children's Wisconsin Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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