Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.
Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy were randomly assigned to the control(placebo) or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or placebo for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Oral olanzapine tablets
Oral placebo
Shanghai Children's Medical Center
Shanghai, China
the CR rate for vomiting in the first 72 hours
The primary endpoint was the CR rate for vomiting in the first 72 hours of the initiation of olanzapine .
Time frame: in the first 72 hours of the initiation of olanzapine
the CR rate for nausea in the first 72 hours of the initiation of olanzapine
The secondary endpoint was the CR rate for nausea in the first 72 hours of the initiation of olanzapine
Time frame: in the first 72 hours of the initiation of olanzapine
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