Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

Medical College of Wisconsin

Status: Terminated

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Device: Sham percutaneous neurostimulation; Device: Auricular percutaneous neurostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05143554

1678523-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 4 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 2 patient groups

Active percutaneous neurostimulation

Active Comparator group

Description:

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)

Treatment:

Device: Auricular percutaneous neurostimulation

Sham percutaneous neurostimulation

Sham Comparator group

Description:

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)

Treatment:

Device: Sham percutaneous neurostimulation