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

February 7, 2022 updated by: Camilla Vieira de Rebouças, Instituto Brasileiro de Controle do Cancer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 03102002
        • IBCC Oncologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea Complete Response Rate
Time Frame: 5 days after chemotherapeutic administration
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
Time Frame: 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
For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)
Complete Control
Time Frame: 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
For the following time periods: 0-24 hours (acute), 24+ to 120 hours (delayed), and 0-120 hours (overall)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Brasileiro de Controle do Cancer

Investigators

  • Principal Investigator: Camilla Rebouças, MD, Instituto Brasileiro de Controle do Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2020

Primary Completion (Actual)

December 17, 2021

Study Completion (Actual)

January 17, 2022

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38285020.8.0000.0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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