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 range

18 Years – 90 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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