Status:
TERMINATED
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Gynecologic Cancer
Eligibility:
FEMALE
18-89 years
Phase:
PHASE3
Brief Summary
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04503668
Start Date
December 28 2020
End Date
March 11 2024
Last Update
June 18 2025
Active Locations (1)
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1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109