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Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine


N/A
4 Years
18 Years
Open (Enrolling)
Both
Acute Leukemia

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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

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