Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

Medical College of Wisconsin18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Chemotherapy-induced Nausea and Vomiting

Interventions

Auricular percutaneous neurostimulationDEVICE

Percutaneous neurostimulation

Sham percutaneous neurostimulationDEVICE

Sham percutaneous neurostimulation

Eligibility

Sex: ALLMin age: 4 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Wisconsin Hospital

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: From the date of baseline assessment up to 7 days after completion of intervention ~ day 13

Data from ClinicalTrials.gov

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