NCT04669132

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Instituto Brasileiro de Controle do Cancer · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Nausea Post Chemotherapy

Interventions

Type	Name	Description
DRUG	Olanzapine	\- Olanzapine 5mg, administered once daily, during 5 days (day before chemotherapy, the D day of the chemotherapy and 3 day after chemotherapy)
DRUG	Netupitant	\- Netupitanto 300 mg, once daily, on chemotherapy day;
DRUG	Palonesetron	\- Palonosetron 0.56 mg, once daily, on chemotherapy day;

Timeline

• Start date: 2020-12-17
• Primary completion: 2021-12-17
• Completion: 2022-01-17
• First posted: 2020-12-16
• Last updated: 2022-02-23

Locations

1 site across 1 country: Brazil