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

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Olanzapine

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Nausea and Vomiting focused on measuring olanzapine, pediatrics, chemotherapy-induced nausea, chemotherapy-induced vomiting

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital, London Health Sciences Centre
Children's Hospital of Eastern Ontario
The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Olanzapine

Arm Description

Outcomes

Primary Outcome Measures

Patient Outcomes

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.

Secondary Outcome Measures

Proportion of Patients With Complete CINV Control

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).

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

All early discontinuation of olanzapine or dose reduction cases will be reported.

Full Information

NCT ID

NCT02129478

First Posted

April 28, 2014

Last Updated

March 24, 2020

Sponsor

The Hospital for Sick Children

Collaborators

Pediatric Oncology Group of Ontario

1. Study Identification

Unique Protocol Identification Number

NCT02129478

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

Collaborators

Pediatric Oncology Group of Ontario

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Nausea and Vomiting

Keywords

olanzapine, pediatrics, chemotherapy-induced nausea, chemotherapy-induced vomiting

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olanzapine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Other Intervention Name(s)

Zyprexa

Intervention Description

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).

Primary Outcome Measure Information:

Title

Patient Outcomes

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Proportion of Patients With Complete CINV Control

Description

Time Frame

During the acute (24 hours) and delayed (7 days after acute phase) phases, up to 2 weeks

Title

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Description

All early discontinuation of olanzapine or dose reduction cases will be reported.

Time Frame

Every day for 30 days after the last dose of the study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lee Dupuis, RPh, PhD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital, London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5W9

Country

Canada

Facility Name

Children's Hospital of Eastern Ontario

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L1

Country

Canada

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G1X8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

28856448

Citation

Flank J, Schechter T, Gibson P, Johnston DL, Orsey AD, Portwine C, Sung L, Dupuis LL. Olanzapine for prevention of chemotherapy-induced nausea and vomiting in children and adolescents: a multi-center, feasibility study. Support Care Cancer. 2018 Feb;26(2):549-555. doi: 10.1007/s00520-017-3864-8. Epub 2017 Aug 30.

Results Reference

result

Links:

URL

http://rdcu.be/vpup

Description

Link to published study results

Learn more about this trial

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

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