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Could a common psychiatric drug ease chemo vomiting in kids?

NCT ID NCT03118986

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 2 times

Summary

This study tests whether adding olanzapine to standard anti-nausea medicines can better control vomiting in children receiving strong chemotherapy. About 200 children will be randomly assigned to get either olanzapine or a placebo. The goal is to see if olanzapine helps more kids avoid vomiting and the need for extra rescue medications.

What this could mean

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

Active substance
olanzapine
What this could lead to
If it works, this could give children a more effective, cheap, and safe option to prevent vomiting during cancer treatment.
What could go wrong
This is a Phase 2 trial, so it's still early. Olanzapine may not work better than placebo, and side effects like drowsiness 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

161 people

The number who actually took part.

Started

Aug 2017

Finished

Jun 2026

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

30 months 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.

Planned receipt of HEC or cyclophosphamide ≥ 1 g/m2/day (≥ 33 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning.81,82 Examples of HEC are: busulfan IV (myeloablative dosing), carboplatin ≥175mg/m²/dose, cisplatin ≥12mg/m²/dose, cytarabine ≥3g/m²/day, melphalan \>140mg/m², methotrexate ≥12g/m²/dose and thiotepa ≥300mg/m²/dose. Plan for inpatient admission from administration of first study drug dose until 24 hours following administration of last study drug dose. Body weight of at least 12.5 kg 2.5 to \< 18 years of age. Note that the minimum age requirement corresponds to an approximate body weight of 12.5 kg. Samples for all laboratory tests will be obtained within one week prior to administration of the first chemotherapy dose of the study chemotherapy block or the first HSCT conditioning dose: * Plasma creatinine within 1.5 times the upper limit of normal for age. * Amylase within age-appropriate limits * Plasma conjugated bilirubin within ≤ 3x upper limit of normal for age unless attributable to Gilbert's Syndrome * ALT ≤ 5x upper limit of normal for age Baseline ECG within the month prior to study drug administration without known clinically significant abnormalities including pathologic prolongation of QTc A plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of chemotherapy or HSCT conditioning. Negative pregnancy test if female of childbearing potential Patients of childbearing potential must consent to use adequate contraception (males and females) or agree to practice abstinence Parent or child able to speak a language in which the (modified Pediatric Adverse Event Rating Scale (PAERS) is available. Optional: Child participants in the optional assessment of nausea severity must be 4 to 18 years of age. Child and a parent/guardian must be English, Spanish or French-speaking. The Pediatric Nausea Assessment Tool58 (PeNAT) is validated in English-speaking children 4 to 18 years old with an English-speaking parent/guardian and has been translated into Spanish and French. The MAT is available in English, Spanish and French.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • All India Institute of Medical Sciences

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Centre Hospitalier Universitaire Sainte-Justine,

    Montreal, Quebec, H3T 1C5, Canada

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • The Children's Mercy Hospital

    Kansas City, Missouri, 64108, United States

  • University of California

    San Francisco, California, 94158, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7220, United States

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