NCT03996863

Prevention of Unmitigated Chemotherapy-induced Emesis

PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Otolith Labs · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to patient care and continues to decrease quality of life. Despite the addition of medications and antiemetic regimens, doctors' ability to control CINV is still inadequate: even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea. In this study, the investigators test a transcranial vibrating system that has shown great promise at reducing nausea and vomiting. .

Detailed description

Chemotherapy-induced nausea and vomiting (CINV) remains a major obstacle to cancer patient care despite numerous medications being available to prevent and treat CINV. CINV decreases quality of life in roughly one third of patients receiving highly emetogenic chemotherapy. In addition, roughly half to two thirds of all patients receiving chemotherapy require rescue anti-emetic medications despite being given guideline-based prophylactic anti-emetics.The anti-emesis armamentarium continues to grow with new medications, including olanzapine and fosaprepitant, being studied in recent years. However, despite the addition of these medications and guideline-based antiemetic regimens, the ability to control CINV is still inadequate as even moderately-emetogenic chemotherapy regimens cause roughly 20% of patients to have vomiting and over 40% to experience significant nausea. In this study, the investigators aim to test a new transcranial vibrating system that has shown promise in phase I studies for treating dizziness, motion sickness and nausea.

Conditions

• Chemotherapy-induced Nausea and Vomiting
• Nausea Post Chemotherapy

Interventions

Type	Name	Description
DEVICE	Otoband	Participants during infusion following chemotherapy will wear the Otoband set at normal power (effective) for four days following treatment and nausea outcomes will be recorded by questionnaire or by the investigator during site visits.
DEVICE	Placebo device	Participants during infusion following chemotherapy will wear the placebo device set at low power (6 decibels lower than normal power, ineffective power) for four days following treatment and nausea outcomes will be recorded by questionnaire or by the investigator during site visits.

Timeline

• Start date: 2019-08-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2019-06-25
• Last updated: 2021-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study