Steroid-sparing Therapy (Olanzapine) Versus Dexamethasone-based Therapy for Chemotherapy-induced Nausea and Vomiting

Description

The purpose of this research is to compare two drugs that are routinely used as standard of care for treating nausea and vomiting caused by chemotherapy. This study aims to see if the drug olanzapine is as good as the steroid drug dexamethasone for preventing nausea and vomiting after chemotherapy. Both drugs are listed as appropriate treatment options in the most recent version of National Comprehensive Cancer Network guidelines on Antiemesis.

Conditions

Chemotherapy-induced Nausea and Vomiting

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Study Overview

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Study Details

Study overview

The purpose of this research is to compare two drugs that are routinely used as standard of care for treating nausea and vomiting caused by chemotherapy. This study aims to see if the drug olanzapine is as good as the steroid drug dexamethasone for preventing nausea and vomiting after chemotherapy. Both drugs are listed as appropriate treatment options in the most recent version of National Comprehensive Cancer Network guidelines on Antiemesis.

The Efficacy of Steroid-Sparing Anti-Emetic Therapy in Patients Treated With High or Moderate Emetogenic Chemotherapy; Single Center Non-Inferiority Open Label Randomized Controlled Trial

Steroid-sparing Therapy (Olanzapine) Versus Dexamethasone-based Therapy for Chemotherapy-induced Nausea and Vomiting

Condition
Chemotherapy-induced Nausea and Vomiting
Intervention / Treatment

-

Contacts and Locations

Sayre

Robert Packer Hospital, Sayre, Pennsylvania, United States, 18840

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years and older
  • * confirmed cancer diagnosis
  • * starting cycle 1 of an FDA approved treatment that is categorized as high-emetogenic (nausea and vomiting inducing) chemotherapy per National Comprehensive Cancer Network® guidelines
  • * Eastern Cooperative Oncology Group performance score of 0 or 1
  • * appropriate renal function
  • * appropriate hepatic function
  • * appropriate hematologic function.
  • * Patients will be excluded if they experience nausea or vomiting up to 24 hours before chemotherapy,
  • * currently on a glucocorticoid therapy
  • * contraindication to glucocorticoid therapy
  • * taking any medication that has antiemetic properties.
  • * scheduled or planned to receive radiation within one week of or concurrently with chemotherapy
  • * brain metastases.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Guthrie Clinic,

Zane Waite, PharmD, BCOP, PRINCIPAL_INVESTIGATOR, The Guthrie Clinic

Study Record Dates

2024-11-01