Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01661413|
Recruitment Status : Unknown
Verified July 2013 by Angela Punnett, The Hospital for Sick Children.
Recruitment status was: Recruiting
First Posted : August 9, 2012
Last Update Posted : July 30, 2013
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||December 2013|
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.
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): NCT01661413
|Contact: Angela Punnett, MD||(416)email@example.com|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Angela Punnett, MD (416)813-7703 firstname.lastname@example.org|
|Principal Investigator: Angela Punnett, MD|
|Principal Investigator: Lee Dupuis, MD|
|Principal Investigator:||Angela Punnett, MD||The Hospital for Sick Children|
|Principal Investigator:||Lee Dupuis, MD||The Hospital for Sick Children|