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Olanzapine for Cancer-Related Nausea and Vomiting

Q: 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.

Q: Are there multiple facilities conducting this investigation in the U.S. and Canada?

Currently, 9 clinical trial sites are operating this study in <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, 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.

Q: 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 <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, NY or Nationwide Children's Hospital in Columbus, <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>.

Q: 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 <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> City.

Q: 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 <a href="https://www.withpower.com/clinical-trials/depression">depression</a>.

Q: 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.

Q: 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.

Q: 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 &#x26; Company back in 2007 with a cohort of 20 participants; following that initial trial, 382 studies have already been concluded.

Q: 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.

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

Awards & highlights

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.

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.Check my eligibility

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.See study design

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 below

Select...

I am not pregnant.

Select...

I am scheduled for high-dose chemotherapy or a stem cell transplant.

Select...

My lab tests for the study were done within a week before starting chemotherapy or HSCT.

Select...

My liver enzyme ALT levels are within 5 times the normal range.

Select...

My weight is at least 12.5 kg.

Select...

My kidney function, measured by creatinine, is within the normal range for my age.

Select...

My recent heart test (ECG) showed no significant issues.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of CIV control during the acute phase

Secondary outcome measures

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 more

Trial 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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER

2,505 Previous Clinical Trials

15,237,355 Total Patients Enrolled

University of North Carolina, Chapel HillOTHER

1,508 Previous Clinical Trials

4,190,842 Total Patients Enrolled

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,306 Total Patients Enrolled

Media Library

Olanzapine Clinical Trial Eligibility Overview. Trial Name: NCT03118986 — Phase 2

Gastroenteritis Research Study Groups: Olanzapine, Placebo Oral Tablet

Gastroenteritis Clinical Trial 2023: Olanzapine Highlights & Side Effects. Trial Name: NCT03118986 — Phase 2

Olanzapine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03118986 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

PharmacotherapyJournal

Development and Validation of the Pediatric Nausea Assessment Tool for Use in Children Receiving Antineoplastic Agents

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.

clinicaltrials.govStudy

RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy

Lee Dupuis 2017. "RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03118986.

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