Olanzapine for Prevention of Chemotherapy-induced Nausea and Vomiting in Children: A Multi-Centre Feasibility Study
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
Olanzapine is licensed for use in adults in Canada and in teens in the US with mental
illness. It is also often used for the management of mental illness in children. This study
will describe the feasibility of giving olanzapine plus other usual medications to prevent
chemotherapy induced nausea and vomiting (CINV) to 15 children aged 4 to 18 years.
What has been done already? - In adult cancer patients, olanzapine improved the control of
CINV. None of the adults studied experienced any serious side effects from olanzapine.
What is being studied and how will the study be conducted? - On each day that chemotherapy is
given, olanzapine will be given to 15 children along with their regular medications to
prevent CINV. Investigators will study each child only during one chemotherapy cycle.
Participants' blood sugar, liver function tests (AST and ALT), prolactin and triglyceride
levels, blood pressure, weight, mood and behavior during the time they receive olanzapine
will be evaluated to see if they change. Investigators will record anything serious that
happens while children receive olanzapine. If any child stops olanzapine early or decides to
decrease the dose, the reason will be recorded. Each child and their guardian will record
their nausea severity and the times they vomit or retch on each day they receive chemotherapy
and for 8 days afterwards.
How will the study help? - This study will help investigators decide if it is feasible to
conduct a larger study to find out if olanzapine improves CINV control in children. If most
children are able to take olanzapine as set out in the study without having significant side
effects, then a larger study would be feasible.