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Prevention of Unmitigated Chemotherapy-induced Emesis

NCT03996863 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-04-27

No results posted yet for this study

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. .

Conditions

  • Chemotherapy-induced Nausea and Vomiting
  • Nausea Post Chemotherapy

Interventions

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.

Sponsors & Collaborators

  • Drexel University College of Medicine

    collaborator OTHER

  • Otolith Labs

    lead INDUSTRY

Principal Investigators

  • Michael S Sherman, MD · Drexel University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2019-08-01
Completion
2019-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03996863 on ClinicalTrials.gov