CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 91 enrolled
Drug / intervention
Olanzapine 5 MG +1 moredrug
Likely dose
Olanzapine 5 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04535141
NCT04535141Phase 3Completed

Addition of Olanzapine to Standard CINV Prophylaxis in Hematopoietic Stem Cell Transplant

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Sep 1, 2020·Updated May 9, 2023

In Brief

A Phase 3 clinical trial evaluating Olanzapine 5 MG and Placebo for Chemotherapy-induced Nausea and Vomiting. Completed, enrolled 91 participants across 1 site.

Detailed Summary

The purpose of this research study is to see if olanzapine helps to prevent nausea and/or vomiting (throwing up) when it is added to other medicines in subjects having stem cell transplants. Subjects will either be given olanzapine or an inactive pill (called a placebo) before getting any chemotherapy that is known to cause nausea and vomiting. During the study, the study coordinators will ask the subjects to complete surveys to understand if the patient is having nausea and vomiting, and if so, how bad it is making the patient feel. This trial will split subjects into two groups: one group will be given an inactive pill (placebo), and the other group will be given the active pill (olanzapine). Study coordinators will collect surveys every morning before chemotherapy and 5 days after the last dose of chemotherapy. These surveys may be given by members of the study team or possibly on a mobile device. Subjects may benefit from being in this research study because olanzapine may reduce the frequency or severity of chemotherapy-induced nausea and vomiting (CINV). The most common risks of using olanzapine include possibly becoming more tired, mild dizziness, mild low blood pressure, and mild muscle "quivering." Other possible adverse effects include low blood pressure, muscle weakness, increased appetite, weight gain, constipation, and liver function test changes however these risks are less common in subjects with cancer. In addition, there may be a change detected in heart rhythm however subjects will be screened for this ahead of time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 1, 2020
Enrollment StartAug 18, 2020
Primary CompletionApr 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.8 years ago

Interventions

Olanzapine 5 MGdrug

It will be a de-identified pill created by investigational drug services at University of North Carolina

Placebodrug

It will be a de-identified pill created by investigational drug services at University of North Carolina