UnknownPhase 3

the Efficacy and Safety of Ondansetron Oral Soluble Pellicles

China184 participantsStarted 2024-02-20

Plain-language summary

The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy.

Who can participate

Age range

18 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

. Age ≥18 years, gender is not limited;
. Histologically or cytologically confirmed diagnosis of malignant solid tumor;
. Initial highly emetogenic one-day chemotherapy regimen (cisplatin dose 60-75 mg/m2; anthracycline compound adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ); and
. Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetron orally dissolved membrane + dexamethasone started before chemotherapy;
. Expected survival ≥ 3 months;
. Eastern Cooperative Oncology Group (ECOG) physical status score ≤2;
. Patients were able to read, understand, and complete study questionnaires;
. Patients understood the study procedures and signed a written informed consent form

Exclusion criteria

. Patients scheduled to receive multiple days of highly emetogenic chemotherapy within one week;
. Patients using an antiemetic drug other than the study drug or a drug with an antiemetic active ingredient within 48 h prior to initiation of randomization and/or within one week of enrollment;

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

Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups

Timeframe: 21 days

Trial details

NCT IDNCT06282211

SponsorThe First Affiliated Hospital of Xinxiang Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

Contact for this trial

Yinghua Ji

13663030446 54234317@qq.com

View on ClinicalTrials.gov More Nausea and Vomiting trials