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

Sponsor

Instituto Brasileiro de Controle do Cancer (Other)

Overall Status

Completed

CT.gov ID

NCT04669132

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Post Chemotherapy	Drug: Olanzapine Drug: Netupitant Drug: Palonesetron	Phase 2

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 17, 2020

Actual Primary Completion Date :

Dec 17, 2021

Actual Study Completion Date :

Jan 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olanzapine + Netupitanto + Palonosetron Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;	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;

Arm

Intervention/Treatment

Experimental: Olanzapine + Netupitanto + Palonosetron

Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;

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;

Outcome Measures

Primary Outcome Measures

Nausea Complete Response Rate [5 days after chemotherapeutic administration]
Defined as no nausea and no rescue medication

Secondary Outcome Measures

Complete Emesis Control [For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)]
Defined as no emetic episodes and no use of rescue medications
Complete Control [For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)]
Defined as no nausea, no emesis and no rescue medication