Could a common psychiatric drug ease chemo vomiting in kids?
NCT ID NCT03118986
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
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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
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30 months to 18 years
- Sex
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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 Hide 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
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All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
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Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
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Centre Hospitalier Universitaire Sainte-Justine,
Montreal, Quebec, H3T 1C5, Canada
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Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
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The Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
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University of California
San Francisco, California, 94158, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7220, United States
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