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| Name | Class |
|---|---|
| Pediatric Oncology Group of Ontario | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Dupuis, RPh, PhD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada | ||
| Children's Hospital of Eastern Ontario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28856448 | Result | 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. |
| Label | URL |
|---|---|
| Link to published study results | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Olanzapine | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Olanzapine | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olanzapine | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Lee Dupuis | The Hospital for Sick Children | 416-813-7654 | 309355 | lee.dupuis@sickkids.ca |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
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| 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 | 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 |
| Ottawa |
| Ontario |
| K1H 8L1 |
| Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G1X8 | Canada |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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|
| Secondary | 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). | Posted | Count of Participants | Participants | During the acute (24 hours) and delayed (7 days after acute phase) phases, up to 2 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Every day for 30 days after the last dose of the study drug |
|
|
|
| 0 |
| 15 |
| 8 |
| 15 |
| Blurry vision | Eye disorders | Systematic Assessment |
|
| Increased plasma GGT values | Blood and lymphatic system disorders | Systematic Assessment |
|
| Mild dizziness | General disorders | Systematic Assessment |
|
| Mild orthostatic hypotension | General disorders | Systematic Assessment |
|
| Hypertriglyceridemia | Cardiac disorders | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |