Clinical Trials Directory

Trials / Completed

CompletedNCT01661413

Nausea and Vomiting in Children Receiving Chemotherapeautic Monotherapy

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

Status
Completed
Phase
Study type
Observational
Enrollment
88 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
4 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2012-05-07
Primary completion
2015-10-31
Completion
2015-10-31
First posted
2012-08-09
Last updated
2019-11-18

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01661413. Inclusion in this directory is not an endorsement.