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Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy. Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during treatment reported by paediatric cancer survivors. Complete prevention of both nausea and vomiting is the goal of anti-vomiting and nausea medications. It is important to understand whether or not certain chemotherapeutic treatments are more or less likely to cause these symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal methotrexate is an important part of chemotherapy for the prevention and treatment of central nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal methotrexate will cause nausea and vomiting will therefore be important to optimize treatment for these side-effects of chemotherapy. The primary aim of this prospective study is to evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Leukemia | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute Chemotherapy-Induced Nausea and Vomiting | 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. | Over 24 hours after receiving intrathecal methotrexate on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipatory Chemotherapy-Induced Nausea and Vomiting | 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. | Baseline |
| Delayed Chemotherapy-Induced Nausea and Vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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Receiving intrathecal methotrexate in the context of maintenance therapy for acute lymphoblastic leukemia and as dosed by age per protocol. Patients will also receive their protocol driven maintenance chemotherapy which includes oral 6 mercaptopurine and may include IV vincristine and an oral steroid pulse (prednisone or dexamethasone). Oral methotrexate is typically held the weeks that patients receive intrathecal methotrexate during maintenance therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Angela Punnett, MD | The Hospital for Sick Children | Principal Investigator |
| Lee Dupuis, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate |