Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study

March 24, 2020 updated by: Lee Dupuis, The Hospital for Sick Children

Olanzapine is licensed for use in adults in Canada and in teens in the US with mental illness. It is also often used for the management of mental illness in children. This study will describe the feasibility of giving olanzapine plus other usual medications to prevent chemotherapy induced nausea and vomiting (CINV) to 15 children aged 4 to 18 years.

What has been done already? - In adult cancer patients, olanzapine improved the control of CINV. None of the adults studied experienced any serious side effects from olanzapine.

What is being studied and how will the study be conducted? - On each day that chemotherapy is given, olanzapine will be given to 15 children along with their regular medications to prevent CINV. Investigators will study each child only during one chemotherapy cycle. Participants' blood sugar, liver function tests (AST and ALT), prolactin and triglyceride levels, blood pressure, weight, mood and behavior during the time they receive olanzapine will be evaluated to see if they change. Investigators will record anything serious that happens while children receive olanzapine. If any child stops olanzapine early or decides to decrease the dose, the reason will be recorded. Each child and their guardian will record their nausea severity and the times they vomit or retch on each day they receive chemotherapy and for 8 days afterwards.

How will the study help? - This study will help investigators decide if it is feasible to conduct a larger study to find out if olanzapine improves CINV control in children. If most children are able to take olanzapine as set out in the study without having significant side effects, then a larger study would be feasible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • 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 Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Children's Hospital, London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • The Hospital for Sick Children

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

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 4 to 18 years old
  • English-speaking and have an English-speaking parent/guardian
  • Have the minimum cognitive ability of a 4 year old as assessed by a health care professional
  • Scheduled to receive moderately to highly emetogenic chemotherapy as assessed using the Pediatric Oncology Group of Ontario Guideline for emetogenicity Classification of Antineoplastic Agents in Children on at least one day of a course of chemotherapy
  • Scheduled to receive either ondansetron, granisetron or palonosetron with or without dexamethasone on a scheduled basis as ordered by the patient's clinical team as per the usual antiemetic standard of care
  • Weigh at least 14kg
  • Have serum total bilirubin ≤ 3 mg/dl (50 µmol/L), and ALT and AST ≤ 3x upper limit of normal for age
  • Consent to use adequate contraception or remain abstinent on each day olanzapine is given and for 5 days afterward if of child-bearing potential

Exclusion Criteria:

  • Brain tumor patients
  • Have had treatment within 14 days prior to study enrollment with olanzapine or 30 days prior to study enrollment with another antipsychotic agent
  • Planned to receive amifostine, CYP1A2 inducers or inhibitors, other antipsychotic agents or quinolone antibiotics while receiving olanzapine;
  • Have uncontrolled hypertension
  • Receive other antipsychotic agents, amifostine, citalopram, CYP1A2 inducers or inhibitors, quinolone antibiotics while receiving olanzapine
  • Receive scopolamine patches, phenothiazines, acupressure or acupuncture during the study period
  • Planned to receive any antiemetic agents other than dexamethasone, ondansetron, granisetron, palonosetron, aprepitant or fosaprepitant on a scheduled basis
  • Have a history of neuroleptic malignant syndrome, a seizure disorder, hypersensitivity to olanzapine, cardiac arrhythmias including prolonged QT, low left ventricular ejection fraction, or a history of uncontrolled diabetes mellitus
  • Are pregnant or breast-feeding

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olanzapine
Drug: Olanzapine

Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy.

Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg).

Other Names:
  • Zyprexa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Outcomes
Time Frame: 1 year
Our primary study outcome evaluated the feasibility of a future trial of olanzapine that would evaluate the contribution of olanzapine to chemotherapy-induced nausea and vomiting (CINV) control in pediatric oncology patients. A future trial was considered feasible if the following patient outcomes were met: mean time to enroll 15 patients was 12 months or less per site, 12 or more patients took at least half of the planned olanzapine doses, and 3 or less patients experienced significant sedation or dizziness despite dose reduction.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Complete CINV Control
Time Frame: During the acute (24 hours) and delayed (7 days after acute phase) phases, up to 2 weeks
The proportion of children achieving complete CINV control (no nausea, vomiting, or retching and no use of breakthrough antiemetic agents) during the acute (24 hours after the last dose of chemotherapy is administered) and delayed phases (the 7 days following the acute phase) will be described. The duration of assessment will depend on the number of days each individual patient receives chemotherapy. Nausea will be assessed using the Pediatric Nausea Assessment Tool (PeNAT).
During the acute (24 hours) and delayed (7 days after acute phase) phases, up to 2 weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Every day for 30 days after the last dose of the study drug
All early discontinuation of olanzapine or dose reduction cases will be reported.
Every day for 30 days after the last dose of the study drug

Collaborators and Investigators

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

Sponsor

The Hospital for Sick Children

Collaborators

Pediatric Oncology Group of Ontario

Investigators

  • Principal Investigator: Lee Dupuis, RPh, PhD, 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

Helpful Links

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

March 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000040306

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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