Nausea Post Chemotherapy
Conditions
Keywords
olanzapine, emetogenic, chemotherapy, breast cancer, nausea
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).
Interventions
DRUGOlanzapine
\- Olanzapine 5mg, administered once daily, during 5 days (day before chemotherapy, the D day of the chemotherapy and 3 day after chemotherapy)
DRUGNetupitant
\- Netupitanto 300 mg, once daily, on chemotherapy day;
DRUGPalonesetron
\- Palonosetron 0.56 mg, once daily, on chemotherapy day;
Sponsors
Instituto Brasileiro de Controle do Cancer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Complete Response Rate | 5 days after chemotherapeutic administration | Defined as no nausea and no rescue medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed