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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04669132
Study type Interventional
Source Instituto Brasileiro de Controle do Cancer
Contact
Status Completed
Phase Phase 2
Start date December 17, 2020
Completion date January 17, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03478605 - Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis Phase 2
Completed NCT03572829 - Aprepitant for Nause and Vomiting Induced by Chemoradiotherapy in HNSCC Phase 2
Completed NCT01504711 - Fosaprepitant Dimeglumine in Preventing Nausea and Vomiting in Patients With Gastrointestinal Cancer Receiving Combination Chemotherapy N/A
Recruiting NCT04141514 - Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy N/A
Not yet recruiting NCT05272865 - Pharmacokinetic and Pharmacodynamic Evaluation of Formulations of Δ9-THC Phase 1/Phase 2
Withdrawn NCT03996863 - Prevention of Unmitigated Chemotherapy-induced Emesis N/A