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Clinical Trial Summary

Children aged 2-12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm-A (fosaprepitant) or arm-B (aprepitant). Children recruited to arm-A received intravenous granisetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm-B received the same drugs as those given to children in arm-A, except that fosaprepitant was substituted with aprepitant. Granisetron and dexamethasone were given continuously until 48 hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04873284
Study type Interventional
Source Shanghai Children's Medical Center
Contact Li-Ting Yu, MD
Phone 021-38626161
Email yuliting@scmc.com.cn
Status Not yet recruiting
Phase N/A
Start date May 1, 2021
Completion date December 30, 2021

See also
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Completed NCT01402024 - Study to Evaluate Anti-emetic Effect of Aprepitant Versus Placebo in Children and Adolescent Receiving Chemotherapy Phase 3
Completed NCT00211601 - Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041) N/A
Completed NCT05792228 - A Standardized Intervention to Improve the Management of Chemotherapy-induced Nausea and Vomiting N/A
Withdrawn NCT01596426 - Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years Phase 1
Withdrawn NCT01596413 - Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years Phase 1