RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-12-07
Study Completion:2024-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05590923

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years and older
  2. * confirmed cancer diagnosis
  3. * 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
  4. * Eastern Cooperative Oncology Group performance score of 0 or 1
  5. * appropriate renal function
  6. * appropriate hepatic function
  7. * appropriate hematologic function.
  1. * Patients will be excluded if they experience nausea or vomiting up to 24 hours before chemotherapy,
  2. * currently on a glucocorticoid therapy
  3. * contraindication to glucocorticoid therapy
  4. * taking any medication that has antiemetic properties.
  5. * scheduled or planned to receive radiation within one week of or concurrently with chemotherapy
  6. * brain metastases.

Contacts and Locations

Study Contact

Zane Waite, PharmD, BCOP
CONTACT
570-887-6072
zane.waite@guthrie.org
Kelly Wurzler, PharmD
CONTACT
kelly.wurzler@guthrie.org

Principal Investigator

Zane Waite, PharmD, BCOP
PRINCIPAL_INVESTIGATOR
The Guthrie Clinic

Study Locations (Sites)

Robert Packer Hospital
Sayre, Pennsylvania, 18840
United States

Collaborators and Investigators

Sponsor: The Guthrie Clinic

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

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 Registration Dates

Study Start Date2022-12-07
Study Completion Date2024-11-01

Study Record Updates

Study Start Date2022-12-07
Study Completion Date2024-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chemotherapy-induced Nausea and Vomiting