Chemotherapy-induced Nausea and Vomiting
Conditions
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.
Interventions
Percutaneous neurostimulation
DEVICESham percutaneous neurostimulation
Sham percutaneous neurostimulation
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
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 chemotherapy
Eligibility
Sex/Gender
ALL
Age
4 Years to 30 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed