Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer — OLNEPA  

Nausea Post Chemotherapy Clinical Trial

Official title: Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer

Status Completed

Clinical Trial Summary

This is a longitudinal, one arm, prospective phase II study, designed to evaluate the efficacy of Olanzapine Netupitant and Palonosetron in the controll of nausea and vomiting induced by highly emetogenic chemotherapy.

Clinical Trial Description

The population of the study is women diagnosed with breast cancer, who will start chemotherapy (Doxorubicine and Cyclophosfamide). We will evaluate the control of nausea and vomiting in the first cycle of chemotherapy, utilizing Netupitant (300mg) + palonosetron (0,56mg) in day 1 and Olanzapine 5mg starting on Day 0, given once a day for five days. The primary endpoint of this study is complete response rate (no nausea, no emesis no use of rescue medication). ;

Related Conditions & MeSH terms

• Nausea
• Nausea Post Chemotherapy
• Vomiting

• NCT number: NCT04669132
• Study type: Interventional
• Source: Instituto Brasileiro de Controle do Cancer
• Status: Completed
• Phase: Phase 2
• Start date: December 17, 2020
• Completion date: January 17, 2022