WithdrawnNot Applicable

Prevention of Unmitigated Chemotherapy-induced Emesis

Stopped: Drexel Oncology was shut down a few days before first patient in.

United States0Started 2019-08-01

Plain-language 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. .

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject currently receiving chemotherapy known to be emetogenic (i.e subject has already received one round of chemotherapy) * MASCC Antiemesis Tool score of \> 6 on the nausea severity scale and/or * One or more episodes of vomiting anytime in the 4 days following receipt of chemotherapy and/or * The need for three or more uses of rescue antiemetic medications within 4 days of chemotherapy during previous round. Exclusion Criteria: * Pregnant women * Individuals unable to provide informed consent * Any preexisting condition causing significant nausea or vomiting, or causing reaction to the bone conduction system (e.g. superior canal dehiscence) * Prisoners

What they're measuring

Change in MAT (MASCC Antiemesis Tool) score

Timeframe: MAT score is obtained on day 5 following each of the three chemotherapy treatments.

Trial details

NCT IDNCT03996863

SponsorOtolith Labs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-01

View on ClinicalTrials.gov More Chemotherapy-induced Nausea and Vomiting trials