Clinical trial NCT01661413: Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy
Official title: Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukemia
Keywords: Acute Leukemia
Pediatrics
Intrathecal methotrexate
Chemotherapy
Nausea
Vomiting
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 88
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acute Chemotherapy-Induced Nausea and Vomiting
timeFrame: Over 24 hours after receiving intrathecal methotrexate on day 1
Secondary outcomes:
measure: Anticipatory Chemotherapy-Induced Nausea and Vomiting
timeFrame: Baseline
measure: Delayed Chemotherapy-Induced Nausea and Vomiting
timeFrame: Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Angela Punnett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Lee Dupuis, MD
role: PRINCIPAL_INVESTIGATOR
References: