Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT04503668
Eligibility Criteria:
Inclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT04503668
Study Brief:
Protocol Section:
NCT04503668