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

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ClinicalTrials.gov Identifier: NCT02129478
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Pediatric Oncology Group of Ontario
Information provided by (Responsible Party):
Lee Dupuis, The Hospital for Sick Children

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.


Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Drug: Olanzapine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study
Study Start Date : March 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


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 Name: Zyprexa




Primary Outcome Measures :
  1. Proportion of patients with complete CINV control [ Time Frame: Up to 2 weeks ]
    The proportions 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).


Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: At least 30 days ]
    The incidence and severity of adverse effects and the presence of hyperglycemia, glucosuria (dipstick), and hypo/hypertension will be reported. Changes in body weight, plasma AST/ALT, prolactin, and triglyceride concentrations will also be presented. A parent/guardian/caregiver will complete the Side Effect Rating Scale (SERs) at least twice while their child is receiving olanzapine. All reasons for early discontinuation of olanzapine or dose reduction will be described.



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 dexamethason 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 antiphychotic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129478


Locations
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Canada, Ontario
Children's Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Pediatric Oncology Group of Ontario
Investigators
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Principal Investigator: Lee Dupuis, RPh, PhD The Hospital for Sick Children

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Responsible Party: Lee Dupuis, Pharmacy Clinical Manager, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02129478     History of Changes
Other Study ID Numbers: 1000040306
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Lee Dupuis, The Hospital for Sick Children:
olanzapine
pediatrics
chemotherapy-induced nausea
chemotherapy-induced vomiting

Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents