Efficacy of Auricular Neurostimulation for Children Adolescents and Young Adults With Chemotherapy Induced Nausea and Vomiting
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Change in Rhodes Index of Nausea, Vomiting and Retching (INVR)
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 4 Years to 30 Years (Child, Adult)
- Sex
- 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
Arms & Interventions
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)
Intervention: Auricular percutaneous neurostimulation (Device)
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)
Intervention: Sham percutaneous neurostimulation (Device)
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Angela Steineck
Assistant Professor
Medical College of Wisconsin