Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy
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|ClinicalTrials.gov Identifier: NCT01661413|
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : November 18, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||88 participants|
|Official Title:||Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine|
|Actual Study Start Date :||May 7, 2012|
|Actual Primary Completion Date :||October 31, 2015|
|Actual Study Completion Date :||October 31, 2015|
Children diagnosed with acute leukemia, undergoing chemotherapy. Patients with acute leukemia will receive intrathecal methotrexate on day 1 plus intravenous vincristine on day 1 plus oral steroid on days 1-5 plus their regularly scheduled and ongoing daily oral 6-mercaptopurine at the start of a maintenance therapy cycle.
- Acute Chemotherapy-Induced Nausea and Vomiting [ Time Frame: Over 24 hours after receiving intrathecal methotrexate on day 1 ]To describe the prevalence of acute phase CINV in these patients. Acute CINV is defined as nausea, vomiting or retching occurring within the first 24 hours following chemotherapy.
- Anticipatory Chemotherapy-Induced Nausea and Vomiting [ Time Frame: Baseline ]To describe the prevalence of anticipatory nausea and vomiting in these patients. Anticipatorty nausea and vomiting begins prior to the administration of chemotherapy in patients who have previously received chemotherapy.
- Delayed Chemotherapy-Induced Nausea and Vomiting [ Time Frame: Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate ]To describe the prevalence of delayed phase CINV in these patients. Delayed CINV develops after the initial 24 hours and might last up to 7 days.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661413
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Angela Punnett, MD||The Hospital for Sick Children|
|Principal Investigator:||Lee Dupuis, MD||The Hospital for Sick Children|