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Corticosteroid
Olanzapine vs Dexamethasone for Chemo-Related Nausea and Vomiting
Phase 4
Recruiting
Led By Nicole Ink, PharmD
Research Sponsored by The Guthrie Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 hours after chemotherapy
Awards & highlights
Study Summary
This trial will compare two drugs used to treat chemo-related nausea/vomiting to see which works best. Olanzapine & dexamethasone are both listed in NCCN guidelines.
Who is the study for?
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.Check my eligibility
What is being tested?
The study compares Olanzapine (an antipsychotic drug) with Dexamethasone (a steroid), both approved treatments for preventing chemotherapy-induced nausea and vomiting. The goal is to determine if Olanzapine can be an alternative to the standard Dexamethasone therapy without compromising effectiveness.See study design
What are the potential side effects?
Olanzapine may cause drowsiness, weight gain, increased appetite, dry mouth or restlessness. Dexamethasone might lead to insomnia, increased appetite leading to weight gain, indigestion or mood swings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 120 hours after chemotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 hours after chemotherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacotherapy
Secondary outcome measures
Complete control (CC- no emesis, no rescue medication and no more than minimal nausea)
Severity of nausea and vomiting self-reported by patient questionnaire
Nausea
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OLA then crossover to DEXExperimental Treatment2 Interventions
OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 1 on days 1-4 after HEC (or days 1-3 after MEC).
DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 2 on days 2-4 after HEC (or days 2-3 after MEC)
Group II: DEX then crossover to OLAActive Control2 Interventions
DEX group: dexamethasone (Decadron) 8 mg oral daily after chemotherapy cycle 1 on days 2-4 after HEC (or days 2-3 after MEC)
OLA group: olanzapine (Zyprexa) 10 mg oral each night after chemotherapy cycle 2 on days 1-4 after HEC (or days 1-3 after MEC).
Find a Location
Who is running the clinical trial?
The Guthrie ClinicLead Sponsor
25 Previous Clinical Trials
1,764 Total Patients Enrolled
Nicole Ink, PharmDPrincipal InvestigatorThe Guthrie Clinic
Zane Waite, PharmD, BCOPPrincipal InvestigatorThe Guthrie Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for radiation soon or at the same time as chemotherapy.I am fully active or can carry out light work.My blood counts are within normal ranges.My liver is working well.I am starting a treatment known to cause severe nausea, as per guidelines.I am 18 years old or older.I am taking medication that helps prevent vomiting.My cancer has spread to my brain.I have had nausea or vomiting within 24 hours before my chemotherapy.I am currently taking glucocorticoid medication.I cannot take steroid medications due to health reasons.I have a confirmed cancer diagnosis.My kidneys are working well.
Research Study Groups:
This trial has the following groups:- Group 1: OLA then crossover to DEX
- Group 2: DEX then crossover to OLA
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How perilous is the switch from OLA to DEX for those undergoing treatment?
"The safety of OLA followed by DEX was rated a 3 because it has been approved by the governing body and is in Phase 4 clinical trials."
Answered by AI
What is the total recruitment of participants for this trial?
"Affirmative, the data located on clinicaltrials.gov verifies that enrollment is still open for this research study which was originally posted on December 7th 2022. Last modified January 12th 2023, it is currently recruiting 104 individuals at a single location."
Answered by AI
Is there a recruitment period currently open for this trial?
"Affirmative. Clinicaltrials.gov contains information suggesting that this clinical trial is currently looking for participants; it was first advertised on December 7th 2022 and the most recent update was January 12th 2023. There are 104 slots at a single location available for enrollment in this study."
Answered by AI
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