RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy

October 3, 2025 updated by: Lee Dupuis, The Hospital for Sick Children

Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy

Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving highly emetogenic chemotherapy (HEC), including those receiving hematopoietic stem cell transplant (HSCT) conditioning, experience CIV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving highly emetogenic chemotherapy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • Hospital for Sick Children
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Terminated
        • Centre Hospitalier Universitaire Sainte-Justine,
  • India
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
  • United States
    • California
      • San Francisco, California, United States, 94158
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • The Children's Mercy Hospital
        • Contact:
          • Judy Vun
          • Phone Number: (816) 302-6797
    • New York
      • New York, New York, United States, 10032
        • Withdrawn
        • Columbia University/Morgan Stanley Children's Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7220
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
    • Ohio
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Shanta Salzer
          • Phone Number: 843-792-1463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Olanzapine
Standard antiemetics plus olanzapine
Drug: Olanzapine
olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
Placebo Comparator: Placebo Oral Tablet
Standard antiemetics plus placebo
Drug: Placebo Oral Tablet
Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of CIV control during the acute phase
Time Frame: up to 8 days
Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during phase
up to 8 days
Rate of CIV control during the acute phase
Time Frame: up to 8 days
Partial control is defined as no more than two vomits or retches during any 24-hr period
up to 8 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety profile of olanzapine based on toxicities
Time Frame: up to 1 month
Based on descriptive statistics on reported toxicities.
up to 1 month
Safety profile of olanzapine based on weight
Time Frame: up to 1 month
Based on descriptive statistics on reported body weight
up to 1 month
Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)
Time Frame: up to 1 month
Based on descriptive statistics on reported PAERs, will describe the most reported and most bothersome adverse events reported in the PAERs questionnaire.
up to 1 month
Safety profile of olanzapine based on prolactin
Time Frame: up to 1 month
Based on descriptive statistics on reported prolactin, will report incidence of abnormal prolactin values comparing the two arms
up to 1 month
Safety profile of olanzapine based on amylase
Time Frame: up to 1 month
Based on descriptive statistics on reported amylase, will report incidence of abnormal amylase values comparing the two arms
up to 1 month
Safety profile of olanzapine based on creatine phophotase
Time Frame: up to 1 month
Based on descriptive statistics on reported creatine phophotase, will report incidence of abnormal creatine phophotase values comparing the two arms
up to 1 month
Safety profile of olanzapine based on triglycerides
Time Frame: up to 1 month
Based on descriptive statistics on reported triglycerides, will report incidence of abnormal triglyceride values comparing the two arms
up to 1 month
Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease
Time Frame: From first HSCT conditioning dose until 100 days post-HSCT
Looking at incidence of veno-occlusive disease
From first HSCT conditioning dose until 100 days post-HSCT
Impact of olanzapine on HSCT outcomes on incidence of GVHD
Time Frame: From first HSCT conditioning dose until 100 days post-HSCT
Looking at incidence of GVHD between the two arms
From first HSCT conditioning dose until 100 days post-HSCT
Impact of olanzapine on HSCT outcomes on severity of GVHD
Time Frame: From first HSCT conditioning dose until 100 days post-HSCT
Comparing the incidence of the different maximal grades of GVHD between the two arms
From first HSCT conditioning dose until 100 days post-HSCT
Association between PeNAT and MASCC Antiemesis Tool (MAT) scores
Time Frame: up to 1 month
taking maximum daily PeNAT scale score and maximum nausea experience in MAT will estimate the degree of association between PeNAT and MAT
up to 1 month
complete and partial CINV control
Time Frame: up to 1 month
Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during phase, Partial control is defined as no more than two vomits or retches during any 24-hr period
up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of South Carolina
Columbia University
University of California, San Francisco
Nationwide Children's Hospital
University of North Carolina, Chapel Hill
Children's Mercy Hospital Kansas City
St. Justine's Hospital
CancerCare Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lee Dupuis, RPh, PhD, The Hospital for Sick Children
  • Principal Investigator: Muhammad Ali, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000053716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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