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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2022
  • participants needed
    170
  • sponsor
    University of Michigan Rogel Cancer Center
Updated on 29 January 2021

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) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.

Details
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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note