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

Instituto Brasileiro de Controle do Cancer

Status and phase: Completed; Phase 2

Conditions: Nausea Post Chemotherapy

Treatments: Drug: Olanzapine; Drug: Netupitant; Drug: Palonesetron

Study type: Interventional

Funder types: Other

Identifiers

NCT04669132

38285020.8.0000.0072

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Olanzapine + Netupitanto + Palonosetron

Experimental group

Description:

Olanzapine 5 mg/day d 0-4 + Netupitanto 300 mg/day d 1 + Palonosetron 0.56 mg/day d 1;

Treatment:

Drug: Palonesetron

Drug: Olanzapine

Drug: Netupitant