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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

Must not have

Diagnosis of psoriasis vulgaris

Infection or severe dermatological condition of ear

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with psoriasis vulgaris.

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I have a severe ear infection or skin condition.

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I have a serious heart or lung condition.

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I have been diagnosed with hemophilia or another bleeding disorder.

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I do not have a severe or uncontrolled infection.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 / 7Eligibility criteria met