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Olanzapine for Cancer-Related Nausea and Vomiting
Phase 2
Recruiting
Led By Tal Schechter-Finkelstein, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Negative pregnancy test if female of childbearing potential
Planned receipt of HEC or cyclophosphamide ≥ 1 g/m2/day (≥ 33 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month
Summary
This trial is testing whether adding the drug olanzapine to standard antiemetics will improve control of CINV in children receiving chemotherapy for HSCT conditioning.
Who is the study for?
This trial is for children aged 2.5 to <18 who are about to receive high-dose chemotherapy or stem cell transplant conditioning and weigh at least 12.5 kg. They must have normal kidney function, liver enzymes, and ECG results, with no severe heart issues. Girls of childbearing age need a negative pregnancy test and agree to use contraception.
What is being tested?
The study tests if Olanzapine added to standard anti-nausea drugs can better prevent vomiting caused by strong chemotherapy in kids compared to a placebo (fake pill). Participants will be randomly assigned either the medication or placebo during their hospital stay.
What are the potential side effects?
Olanzapine may cause side effects such as drowsiness, increased appetite, weight gain, dry mouth, restlessness, and potentially more serious conditions like changes in blood sugar or lipid levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant.
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I am scheduled for high-dose chemotherapy or a stem cell transplant.
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My lab tests for the study were done within a week before starting chemotherapy or HSCT.
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My liver enzyme ALT levels are within 5 times the normal range.
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My weight is at least 12.5 kg.
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My kidney function, measured by creatinine, is within the normal range for my age.
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My recent heart test (ECG) showed no significant issues.
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I am between 2.5 and 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of CIV control during the acute phase
Secondary study objectives
Association between PeNAT and MASCC Antiemesis Tool (MAT) scores
Impact of olanzapine on HSCT outcomes on incidence of GVHD
Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease
+9 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: OlanzapineActive Control1 Intervention
Standard antiemetics plus olanzapine
Group II: Placebo Oral TabletPlacebo Group1 Intervention
Standard antiemetics plus placebo
Find a Location
Who is running the clinical trial?
University of California, San FranciscoOTHER
2,588 Previous Clinical Trials
14,900,807 Total Patients Enrolled
5 Trials studying Nausea
2,400 Patients Enrolled for Nausea
University of North Carolina, Chapel HillOTHER
1,557 Previous Clinical Trials
4,298,852 Total Patients Enrolled
2 Trials studying Nausea
324 Patients Enrolled for Nausea
Nationwide Children's HospitalOTHER
348 Previous Clinical Trials
5,227,869 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant.My liver enzyme ALT levels are within 5 times the normal range.My weight is at least 12.5 kg.My kidney function, measured by creatinine, is within the normal range for my age.My bilirubin levels are normal or slightly elevated, not due to Gilbert's Syndrome.My recent heart test (ECG) showed no significant issues.My child is between 4-18 years old and we speak English, Spanish, or French.I am scheduled for high-dose chemotherapy or a stem cell transplant.My lab tests for the study were done within a week before starting chemotherapy or HSCT.I will stay in the hospital from the first to 24 hours after the last dose of the study drug.My amylase levels are within the normal range for my age.I am between 2.5 and 18 years old.I am scheduled to receive continuous anti-nausea medication during my chemotherapy or stem cell transplant preparation.
Research Study Groups:
This trial has the following groups:- Group 1: Olanzapine
- Group 2: Placebo Oral Tablet
Awards:
This trial has 0 awards, including: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.
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