NCT03079219

Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients

A Randomized Study to Determine the Efficacy and Tolerability of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: CCTU · Academic / Other
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the proportion of patients with Complete Response in the 120 hours following AC chemotherapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Experimental drug: Aprepitant	Day 1: 125mg QD; Day 2 to Day 3: 80mg QD
DRUG	Experimental drug: Ondansetron	Day 1: 8mg BD, First dose 8mg, Second dose 8mg, 8 hours after first dose
DRUG	Experimental drug: Dexamethasone	Day 1: 12mg QD
DRUG	Experimental drug: Olanzapine	Day 1 to Day 5: 10mg QD
DRUG	Standard: Aprepitant	Day 1: 125mg QD, Day 2 to Day3: 80mg QD
DRUG	Standard: Ondansetron	Day 1: 8mg BD, First dose 8mg, second dose 8mg, 8 hours after first dose
DRUG	Standard: Dexamethasone	Day 1: 12mg QD ; Day 2 to Day 3: 4mg BD

Timeline

• Start date: 2017-03-23
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2017-03-14
• Last updated: 2021-07-28

Locations

1 site across 1 country: Hong Kong