NCT04232423

Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

Efficacy and Dosage of Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis in Women With Gynecologic Cancers Receiving Carboplatin-based Regimen : a Double-blind, Placebo-controlled, Randomized Crossover Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Department of Medical Services Ministry of Public Health of Thailand · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo

Detailed description

A double-blind, placebo-controlled, randomized crossover trial

Conditions

• Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis

Interventions

Type	Name	Description
DRUG	Olanzapine 10 Mg ORAL TABLET	* Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4
DRUG	Olanzapine 5 Mg ORAL TABLET	* Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4
DRUG	Placebo ORAL TABLET	* Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1) * Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-06-30
• Completion: 2021-09-30
• First posted: 2020-01-18
• Last updated: 2022-01-21

Locations

1 site across 1 country: Thailand