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Neurostimulation Device

Auricular Neurostimulation for Chemotherapy-Induced Nausea and Vomiting

N/A

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chemotherapy regimens must include moderate and/or severe emetogenic chemotherapy

Subjects who are scheduled to be admitted for chemotherapy administration and who will have at least one additional cycle of the same chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of baseline assessment up to 7 days after completion of intervention ~ day 13

Awards & highlights

Study Summary

This trial looks at using a nerve stimulator to reduce chemo-related nausea/vomiting in kids, teens, and young adults.

Who is the study for?

This trial is for children, adolescents, and young adults who are about to receive chemotherapy that's known to cause moderate or severe nausea and vomiting. They must have at least one more cycle of the same chemo planned. It's not for those with developmental delays affecting participation, ear infections or skin conditions, uncontrolled infections, electrical implants in their body, pregnancy, severe heart/lung disease, bleeding disorders or psoriasis vulgaris.Check my eligibility

What is being tested?

The study is testing a device called an auricular percutaneous electrical nerve field stimulator against a sham (fake) version to see if it can reduce nausea and vomiting caused by chemotherapy. Participants will be randomly assigned to either the real treatment group or the sham control group.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site where the device attaches to the ear. Since this involves neurostimulation rather than drugs, traditional drug-related side effects are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My chemotherapy is known to cause moderate to severe nausea.

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I am scheduled for chemotherapy and will have at least one more round of the same treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of baseline assessment up to 7 days after completion of intervention ( day 13)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of baseline assessment up to 7 days after completion of intervention ( day 13)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of baseline assessment up to 7 days after completion of intervention ( day 13) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of Rescue Medication

Baxter Retching Faces Scale

Change in Rhodes Index of Nausea, Vomiting and Retching (INVR)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active percutaneous neurostimulationActive Control1 Intervention

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)

Group II: Sham percutaneous neurostimulationPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

610 Previous Clinical Trials

1,162,663 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adolescents eligible for this research trial?

"According to the trial parameters, only participants aged 4-30 are eligible. In contrast, 21 studies have been conducted for minors and 73 trials have been developed for elderly individuals over 65 years old."

Answered by AI

Can you provide an upper limit to the amount of participants taking part in this research?

"Affirmative. Clinicaltrials.gov archives show that this research project, which was first published on April 29th 2021, is actively seeking candidates for enrolment. 50 participants need to be found from one medical facility."

Answered by AI

Are there vacancies in this experiment that would allow for additional participants?

"Affirmative, clinicaltrials.gov evidences that this research is recruiting participants. The trial was initially advertised on April 29th 2021 and last modified on September 26th 2023. 50 individuals need to be recruited from 1 medical location for the study's completion."

Answered by AI

Am I eligible to become a participant in this research trial?

"The recruitment criteria for this clinical trial requires that patients have been impacted by nausea and/or vomiting, in addition to being between the ages of 4-30. This medical study is actively seeking 50 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

Angela Steineck 2021. "Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05143554.