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NCT04535141 · ClinicalTrials.gov registry record · Phase 3
Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants
A Phase 3 study, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 91
- Enrollment target
NCT04535141 is a Phase 3 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 91 participants.
The verdict
NCT04535141, a Phase 3 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 91 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Olanzapine 5 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2022-04-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04535141
The ClinicalTrials.gov registry entry for NCT04535141 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04535141 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04535141 about?
NCT04535141 is a clinical study titled "Olanzapine for Nausea/Vomiting Prophylaxis in Recipients of Hematopoietic Stem Cell Transplants". 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 chemothera...
What is the current status of trial NCT04535141?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 91 participants. The study started on 2020-08-18. Estimated completion is 2022-04-11.
What interventions are being tested in trial NCT04535141?
The interventions under investigation include: Placebo (DRUG), Olanzapine 5 MG (DRUG).
Who is sponsoring clinical trial NCT04535141?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
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