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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Nausea Post Chemotherapy

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Netupitant
* Drug: Palonesetron


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine + Netupitanto + Palonosetron<br>Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1; | Drug: Olanzapine<br>* - Olanzapine 5mg, administered once daily, during 5 days (day before chemotherapy, the D day of the chemotherapy and 3 day after chemotherapy)<br>Drug: Netupitant<br>* - Netupitanto 300 mg, once daily, on chemotherapy day;<br>Drug: Palonesetron<br>* - Palonosetron 0.56 mg, once daily, on chemotherapy day;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea Complete Response Rate | Defined as no nausea and no rescue medication | 5 days after chemotherapeutic administration | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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olanzapine, emetogenic, chemotherapy, breast cancer, nausea