Trial Information
Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine
Inclusion Criteria:
- 4 years old to 18 years of age (age range in which the PeNAT has been validated) [18]
- English speaking (PeNAT has been validated only in English)
- Cognitive ability of the child believed to be at least at a 4 year old level
according to parent or health care professional
- Patients are past their first cycle of maintenance therapy to avoid interactions with
the intensive chemotherapy phase.
Exclusion Criteria:
- Receiving chemotherapy other than dictated by protocol for maintenance therapy within
24 hours prior to or 24 hours following receipt of intrathecal methotrexate
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Acute Chemotherapy-Induced Nausea and Vomiting
Outcome Description:
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.
Outcome Time Frame:
Over 24 hours after receiving intrathecal methotrexate on day 1
Safety Issue:
No
Principal Investigator
Angela Punnett, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Hospital for Sick Children
Authority:
Canada: Health Canada
Study ID:
1000030743
NCT ID:
NCT01661413
Start Date:
July 2012
Completion Date:
Related Keywords:
- Acute Leukemia
- Acute Leukemia
- Pediatrics
- Intrathecal methotrexate
- Chemotherapy
- Nausea
- Vomiting
- Leukemia
- Nausea
- Vomiting
- Acute Disease