Clinical trial NCT05143554: Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting
Official title: Efficacy of Auricular Neurostimulation for Children Adolescents and Young Adults With Chemotherapy Induced Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject will be randomized to receive active vs sham therapy, then cross over to the other during the following cycle of chemotherapy
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Baxter Retching Faces Scale
timeFrame: From the date of baseline assessment up to 7 days after completion of intervention ( day 13)
measure: Change in Rhodes Index of Nausea, Vomiting and Retching (INVR)
timeFrame: From the date of baseline assessment and during the intervention (up to day 5)
measure: Assessment of Rescue Medication
timeFrame: From the date of baseline assessment up to 7 days after completion of intervention ~ day 13
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Wisconsin Hospital
state: Wisconsin
Study officials:
References: