Using ear stimulation to reduce nausea and vomiting from chemotherapy
Efficacy of Auricular Neurostimulation for Children Adolescents and Young Adults With Chemotherapy Induced Nausea and Vomiting
NA · Medical College of Wisconsin · NCT05143554
This study is testing if a special ear stimulation can help children, teens, and young adults feel less nausea and vomiting from chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 4 Years to 30 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05143554 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of auricular percutaneous electrical nerve field stimulation in children, adolescents, and young adults experiencing chemotherapy-induced nausea and vomiting (CINV). The research aims to stimulate a branch of the vagus nerve located in the outer ear to potentially alleviate the frequency and severity of nausea and vomiting associated with chemotherapy. Participants will be randomly assigned to receive either active or sham neurostimulation therapy during their chemotherapy cycles, with a crossover to the alternate group in subsequent cycles. The study will monitor nausea, vomiting, the need for additional antiemetic support, and any side effects throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates include children, adolescents, and young adults scheduled for chemotherapy that is known to cause moderate to severe nausea and vomiting.
Not a fit: Patients with significant developmental delays, severe infections, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients undergoing chemotherapy by reducing debilitating nausea and vomiting.
How similar studies have performed: While the use of auricular neurostimulation is a novel approach, similar studies have shown promise in managing nausea and vomiting in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milwaukee, Wisconsin
- Children's Wisconsin Hospital — Milwaukee, Wisconsin, United States (RECRUITING)
Study contacts
- Study coordinator: Paul Harker-Murray, MD
- Email: pharker@mcw.edu
- Phone: 414-955-4108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chemotherapy-induced Nausea and Vomiting