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New drip combo aims to stop chemo nausea in kids

NCT ID NCT05872893

Symptom relief Sponsor: Immune Oncology Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested whether giving a continuous, slow infusion of ondansetron (a common anti-nausea drug) plus dexamethasone (a steroid) could better control nausea and vomiting in children undergoing chemotherapy. The study enrolled 28 children aged 1 day to 18 years with cancer. The goal was to see if this steady delivery method provides longer-lasting relief compared to standard dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ondansetron and dexamethasone
What this could lead to
If it works, this could offer a more effective way to manage chemotherapy-induced nausea and vomiting in children, improving their quality of life during treatment.
What could go wrong
This is a small, completed trial with only 28 participants, so results may not apply to all children. The improvement over standard care may be modest, and side effects like allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

28 people

The number who actually took part.

Started

Jun 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged from 1 day to 18 years who are diagnosed with cancer and are eligible for chemotherapy. * Voluntarily agree to participate by giving written parental permission and child assent. * Patients with sufficient cardiac function, as determined by the investigator. Exclusion Criteria: * Patients with a history of severe hypersensitivity reactions or anaphylaxis related to the use of 5-HT3 receptor antagonists. * Patients receiving concurrent chemo-radiation therapy. * Patients diagnosed with cardiac arrhythmias and congenital long QT interval syndrome. * Known clinically significant drug interactions between chemotherapeutic agents and 5-HT3 receptor antagonists and/or Dexamethasone (e.g. more than 0.8 mg/ml concentrations of 5-fluorouracil may cause precipitation of ondansetron).

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Conditions

The condition(s) this trial relates to.

cancer childhood malignant neoplasm neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pediatric cancer

Contacts and locations

Locations

  • Hematology Center named after prof. R. Yeolyan

    Yerevan, 0014, Armenia

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