The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
NCT Number: NCT01661413
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.
Looking for future studies?
Notify Me4 year–18 year
All sexes
Observational
Toronto, Ontario, M5G 1X8, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Over 24 hours after receiving intrathecal methotrexate on day 1
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.
Time frame: Baseline
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.
Time frame: Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate
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.
The Hospital for Sick Children
Other
Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02445378
Acute Leukemia, Anorexia
Columbus, Ohio, United States
View Trial DetailsNCT06795139
Acute Leukemia, Hematologic Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT07048730
Acute Leukemia, Adnexal Diseases
Bordeaux, France
View Trial DetailsNCT07616635
Acute Leukemia, Haematopoietic Stem Cell Transplantation
Oviedo, Principality of Asturias, Spain
View Trial Details