Chemotherapy-induced Nausea and VomitingNCT05143554
Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting
A study testing Auricular percutaneous neurostimulation in people with Chemotherapy-induced Nausea and Vomiting, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 30 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Auricular percutaneous neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2021to 23 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Wisconsin Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Efficacy of Auricular Neurostimulation for Children Adolescents and Young Adults With Chemotherapy Induced Nausea and Vomiting
This study evaluates the efficacy of auricular percutaneous electrical nerve field stimulator in children, adolescents and young adults with chemotherapy induced nausea and vomiting.
Read the 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Auricular percutaneous neurostimulation, Sham percutaneous neurostimulation
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular percutaneous neurostimulationDevice
Also called IBStim
Percutaneous neurostimulation
Sham percutaneous neurostimulationDevice
Sham percutaneous neurostimulation
| Study group | Role | What they receive |
|---|---|---|
| Active percutaneous neurostimulation | Active comparator | 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) Receives: Device: Auricular percutaneous neurostimulation |
| Sham percutaneous neurostimulation | Sham comparator | 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) Receives: Device: Sham percutaneous neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: From the date of baseline assessment up to 7 days after completion of intervention ~ day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start29 Apr 2021
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Steineck, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143554
- Sponsor's protocol ID
- 1678523-2
- Status last verified
- Sep 2025
- First submitted
- 6 Jul 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Auricular Neurostimulation for Children Adolescents and Young Adults With Chemotherapy Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT05143554
- Acronym / sponsor ID
- 1678523-2
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Active percutaneous neurostimulation | Active comparator | Device: Auricular percutaneous neurostimulationSubject 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) |
| Sham percutaneous neurostimulation | Sham comparator | Device: Sham percutaneous neurostimulationSubject 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) |
Who may qualify
- Ages
- 4 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular percutaneous neurostimulationAlso: IBStimPercutaneous neurostimulation | Device | Active percutaneous neurostimulation |
| Sham percutaneous neurostimulationSham percutaneous neurostimulation | Device | Sham percutaneous neurostimulation |
Primary outcome
Baxter Retching Faces Scale
Time frame: From the date of baseline assessment up to 7 days after completion of intervention ( day 13)
Nausea severity assessed by pictorial nausea faces scale 0-10 (0=no nausea; 10= worse possible nausea) multiple times during hospitalization until discharge
Change in Rhodes Index of Nausea, Vomiting and Retching (INVR)
Time frame: From the date of baseline assessment and during the intervention (up to day 5)
Short 8 item questionnaire to assess severity of nausea, vomiting and retching symptoms
Assessment of Rescue Medication
Time frame: From the date of baseline assessment up to 7 days after completion of intervention ~ day 13
Number of rescue medications to be assessed on daily basis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular percutaneous neurostimulation in people with Chemotherapy-induced Nausea and Vomiting, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baxter Retching Faces Scale (time frame: From the date of baseline assessment up to 7 days after completion of intervention ( day 13)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.