Study 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.
- Cancer
- Nausea
- Gastroenteritis
- Blood Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: up to 1 month
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Olanzapine
1 of 2
Placebo Oral Tablet
1 of 2
Active Control
Non-Treatment Group
200 Total Participants · 2 Treatment Groups
Primary Treatment: Olanzapine · Has Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 30 - 18 · All Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Dupuis, L. Lee, Anna Taddio, Elizabeth N Kerr, Andrea Kelly, and Linda MacKeigan. 2006. “Development and Validation of the Pediatric Nausea Assessment Tool for Use in Children Receiving Antineoplastic Agents”. Pharmacotherapy. Wiley. doi:10.1592/phco.26.9.1221.
- Dupuis LL, Taddio A, Kerr EN, Kelly A, MacKeigan L. Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. Pharmacotherapy. 2006 Sep;26(9):1221-31. doi: 10.1592/phco.26.9.1221.
- Lee Dupuis 2017. "RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03118986.
Frequently Asked Questions
Is the lower age limit for participation in this research open to individuals below the age of 50?
"As outlined in the eligibility requirements, this trial only accepts participants between 30 months and 18 years of age." - Anonymous Online Contributor
Are there multiple facilities conducting this investigation in the U.S. and Canada?
"Currently, 9 clinical trial sites are operating this study in New York, Columbus and Winnipeg as well as 6 other cities. It is beneficial to select a nearby clinic so that the burden of travelling is reduced if you decide to become involved." - Anonymous Online Contributor
How many participants are partaking in this trial?
"200 qualified patients are necessary for this study to be successful. These participants can join the trial at Columbia University/Morgan Stanley Children's Hospital in New York, NY or Nationwide Children's Hospital in Columbus, Ohio." - Anonymous Online Contributor
Is there a body of research that includes Olanzapine in its scope?
"Olanzapine was initially studied in 2007 at VA Puget Sound Health Care System, and now there are 382 completed trials. Currently, 19 clinical studies involving olanzapine are actively recruiting patients, mostly around New York City." - Anonymous Online Contributor
What medical symptoms does Olanzapine typically address?
"Olanzapine is widely employed to treat delusional parasitosis and can be used as a part of an integrated treatment plan for acute agitation, delirium, and unipolar depression." - Anonymous Online Contributor
Are there still opportunities available for prospective participants of this research project?
"The clinicaltrials.gov website details that this investigation, which was initially published on August 10th 2017, is currently recruiting participants. The trial's information has been refreshed as recently as April 1st 2022." - Anonymous Online Contributor
Are there currently any opportunities to engage in this experiment?
"To be eligible for the study, potential volunteers must have nausea and fall between 30 months to 18 years of age. At present, it is expected that 200 participants will take part in this research trial." - Anonymous Online Contributor
What makes this research study distinctive compared to others that have been conducted?
"Currently, 19 trials for Olanzapine are being conducted in 401 cities and 7 countries. This drug was first tested by Eli Lilly & Company back in 2007 with a cohort of 20 participants; following that initial trial, 382 studies have already been concluded." - Anonymous Online Contributor
What is the regulatory status of Olanzapine?
"Olanzapine has garnered a safety rating of 2 due to the absence of evidence for efficacy within Phase 2 trials, and limited data indicating its safety." - Anonymous Online Contributor