Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients

  • End date
    Dec 29, 2022
  • participants needed
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 29 January 2021


The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.

Condition Gynecologic Cancer
Treatment olanzapine, Dexamethasone, ondansetron, Compazine, Neurokinin-1 Receptor Antagonist (NK1-RA)
Clinical Study IdentifierNCT04503668
SponsorUniversity of Michigan Rogel Cancer Center
Last Modified on29 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 89 yrs?
Are you female?
Do you have any of these conditions: Do you have Gynecologic Cancer??
Diagnosis of gynecologic malignancy
No chemotherapy in the last 12 months
Scheduled to receive Carboplatin (AUC>=4) and Paclitaxel every three weeks
ECOG performance status 0 or 1
English speaking
Willing and able to provide informed consent
Laboratory values within protocol-defined parameters
No vomiting in the 24 hours prior to initiating chemotherapy
If childbearing potential exists, negative pregnancy test within 7 days prior to registration

Exclusion Criteria

Significant cognitive compromise
History of CNS disease (e.g. brain metastases, seizure disorder, dementia)
Current or recent (within 30 days) treatment with another antipsychotic agent (antidepressant medications are OK)
Concurrent radiotherapy treatment
Known hypersensitivity to olanzapine
Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the last six months
History of diabetes mellitus on medication (insulin or oral glycemic agent)
Alcohol abuse / chronic alcoholism
History of closed angle glaucoma
Current enrollment in other clinical trials
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