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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
50
\- Olanzapine 5mg, administered once daily, during 5 days (day before chemotherapy, the D day of the chemotherapy and 3 day after chemotherapy)
\- Netupitanto 300 mg, once daily, on chemotherapy day;
\- Palonosetron 0.56 mg, once daily, on chemotherapy day;
IBCC Oncologia
São Paulo, Brazil
Nausea Complete Response Rate
Defined as no nausea and no rescue medication
Time frame: 5 days after chemotherapeutic administration
Complete Emesis Control
Defined as no emetic episodes and no use of rescue medications
Time frame: 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
Time frame: For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)
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