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Completed

NCT Number: NCT04669132

Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast 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.

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Key information

Conditions

Nausea Post Chemotherapy Breast Diseases Breast Neoplasms Nausea Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

IBCC Oncologia

São Paulo, 03102002, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug
  • Olanzapine 5mg, administered once daily, during 5 days (day before chemotherapy, the D day of the chemotherapy and 3 day after chemotherapy)

Netupitant

Drug
  • Netupitanto 300 mg, once daily, on chemotherapy day;

Palonesetron

Drug
  • Palonosetron 0.56 mg, once daily, on chemotherapy day;

Primary outcomes

  1. Nausea Complete Response Rate

    Time frame: 5 days after chemotherapeutic administration

    Defined as no nausea and no rescue medication

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Instituto Brasileiro de Controle do Cancer

Other

Registry information

Acronym: OLNEPA

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 16, 2020
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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