Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients
NCT ID: NCT04503668
Last Updated: 2025-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
62 participants
INTERVENTIONAL
2020-12-28
2024-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Nk1-RA
Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.
Ondansetron
8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy
Dexamethasone
20 mg IV on day 1 pre-chemotherapy
Neurokinin-1 Receptor Antagonist (NK1-RA)
150 mg IV on day 1 pre-chemotherapy
Compazine
5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Olanzapine
Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.
Ondansetron
8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy
Dexamethasone
20 mg IV on day 1 pre-chemotherapy
Olanzapine
5 mg by mouth on days 1-4 of chemotherapy (taken at night)
Compazine
5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Interventions
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Ondansetron
8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy
Dexamethasone
20 mg IV on day 1 pre-chemotherapy
Neurokinin-1 Receptor Antagonist (NK1-RA)
150 mg IV on day 1 pre-chemotherapy
Olanzapine
5 mg by mouth on days 1-4 of chemotherapy (taken at night)
Compazine
5-10 mg by mouth, available as needed, every 6 hours, days 1-5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
89 Years
FEMALE
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Aimee Rolston
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00175458
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2019.173
Identifier Type: -
Identifier Source: org_study_id
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