Auricular Neurostimulation for Chemotherapy Induced Nausea and Vomiting

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05143554
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-induced Nausea and Vomiting	Device: Auricular percutaneous neurostimulation; Device: Sham percutaneous neurostimulation	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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 chemotherapyEach subject will be randomized to receive active vs sham therapy, then cross over to the other during the following cycle of chemotherapy
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Efficacy of Auricular Neurostimulation for Children Adolescents and Young Adults With Chemotherapy Induced Nausea and Vomiting
• Actual Study Start Date: Apr 29, 2021
• Anticipated Primary Completion Date: Apr 29, 2022
• Anticipated Study Completion Date: Apr 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active percutaneous neurostimulation 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)	Device: Auricular percutaneous neurostimulation; Percutaneous neurostimulation; Other Names: IBStim
Sham Comparator: Sham percutaneous neurostimulation 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)	Device: Sham percutaneous neurostimulation; Sham percutaneous neurostimulation

Outcome Measures

Primary Outcome Measures

1. Baxter Retching Faces Scale [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

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

3. Assessment of Rescue Medication [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Wisconsin Hospital	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leonid Melnikov, Pediatric Hematology Oncology Fellow, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT05143554
• Other Study ID Numbers: 1678523-2
• First Posted: Dec 3, 2021
• Last Update Posted: Dec 3, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Nausea; Vomiting

Study Results

No Results Posted as of Dec 3, 2021