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

Phase 2

Completed

• Conditions: Nausea Post Chemotherapy
• Interventions: Drug: Olanzapine; Drug: Netupitant; Drug: Palonesetron

• Registration Number: NCT04669132
• Lead Sponsor: Instituto Brasileiro de Controle do Cancer

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.

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 Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-16
• Study Start: 2020-12-17
• Primary Completion: 2021-12-17
• Study Completion: 2022-01-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Breast cancer hitologically confirmed
• 18 Years and older (Adult, Older Adult)
• Patients about to start use of Doxorubicine 60mg/m2 + Cyclophosfamide 600mg/m2
• No previous chemotherapy for breast cancer

Exclusion Criteria

• Patients not capable of completing the questionnaire
• Patients with other condition that could cause nausea and emesis
• Use of opioids
• Use of antipsychotic medications
• Patients not capable of taking medications orally

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olanzapine + Netupitanto + Palonosetron	Olanzapine	Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;
Olanzapine + Netupitanto + Palonosetron	Palonesetron	Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;
Olanzapine + Netupitanto + Palonosetron	Netupitant	Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;

Primary Outcome Measures

Name	Time	Method
Nausea Complete Response Rate	5 days after chemotherapeutic administration	Defined as no nausea and no rescue medication

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IBCC Oncologia; 🇧🇷 São Paulo, Brazil