Olanzapine vs Dexamethasone for Chemo-Related Nausea and Vomiting
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this research is to compare two drugs that are routinely used as standard of care for treating nausea and vomiting caused by chemotherapy. This study aims to see if the drug olanzapine is as good as the steroid drug dexamethasone for preventing nausea and vomiting after chemotherapy. Both drugs are listed as appropriate treatment options in the most recent version of National Comprehensive Cancer Network guidelines on Antiemesis.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medication that has antiemetic properties (medications that prevent nausea and vomiting) and you cannot be on glucocorticoid therapy (a type of steroid treatment).
Is the combination of olanzapine and dexamethasone safe for preventing chemotherapy-related nausea and vomiting?
Olanzapine and dexamethasone have been studied for safety in preventing nausea and vomiting during chemotherapy. Olanzapine can cause drowsiness, but no major safety issues were reported in studies. Dexamethasone is known for side effects, but its safety in combination with other drugs has been widely evaluated.12345
How is the drug combination of Olanzapine and Dexamethasone unique for treating chemo-related nausea and vomiting?
The combination of Olanzapine and Dexamethasone is unique because it adds Olanzapine, an antipsychotic with anti-nausea properties, to standard antiemetic regimens, potentially enhancing effectiveness against chemotherapy-induced nausea and vomiting, especially in highly emetogenic treatments like those involving cisplatin.12456
What data supports the effectiveness of the drug Olanzapine and Dexamethasone for chemo-related nausea and vomiting?
Research shows that olanzapine is effective in preventing chemotherapy-induced nausea and vomiting, and dexamethasone has been shown to reduce vomiting in patients who did not respond to other treatments. Combining these drugs may help manage nausea and vomiting in cancer patients undergoing chemotherapy.7891011
Who Is on the Research Team?
Zane Waite, PharmD, BCOP
Principal Investigator
The Guthrie Clinic
Are You a Good Fit for This Trial?
This trial is for adults with cancer who are about to start a highly nausea-inducing chemotherapy, as per guidelines. They must be in good physical condition (ECOG score 0 or 1) and have normal kidney, liver, and blood function. It's not for those already on steroids, receiving radiation close to chemo time, with brain metastases, pre-chemo nausea/vomiting, steroid contraindications or taking anti-nausea meds.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Cycle 1
Participants receive either dexamethasone or olanzapine for the first cycle of chemotherapy
Treatment Cycle 2
Participants switch to the other drug (olanzapine or dexamethasone) for the second cycle of chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Olanzapine
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Guthrie Clinic
Lead Sponsor