RESEARCH QUESTION Is prolonged duration of aprepitant treatment better for controlling chemotherapy induced nausea and vomiting (CINV) in children?
HYPOTHESIS Prolonged aprepitant treatment for the total duration of the course of chemotherapy leads to better control of CINV in children.
STUDY DESIGN double-blind placebo-controlled randomized cross-over phase III trial
STUDY POPULATION Children treated in our pediatric oncology hospital with moderate or high emetogenic chemotherapy courses lasting at least 4 days, can participate in this study.
INTERVENTION randomized comparison of standard of care 3-days aprepitant treatment (A) with aprepitant treatment during the total duration of the course of chemotherapy (B). Before starting the next course of similar chemotherapy patients will crossover to the second dosing regimen (A to B and B to A).
OUTCOME MEASURES Proportion of patients who achieved complete response (no vomiting, no retching and no use of rescue medication) during the >24-72 hours after the final dose of chemotherapy.
SAMPLE SIZE/DATA-ANALYSIS For this study 68 patients per treatment group (n=135 number of pairs) are required to have an 90% power to detect a difference of 0.20 between the paired proportions of complete responses for regimens A and B. With an expected dropout rate of 3%, 70 patients per combination of dosing regimens (140 in total) will need to be recruited.