RecruitingPhase 2NCT03118986

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

Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy


Sponsor

The Hospital for Sick Children

Enrollment

200 participants

Start Date

Aug 10, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving highly emetogenic chemotherapy (HEC), including those receiving hematopoietic stem cell transplant (HSCT) conditioning, experience CIV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving highly emetogenic chemotherapy


Eligibility

Min Age: 30 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Olanzapine and a drug called Placebo Oral Tablet for people with hematopoietic system--cancer, nausea, and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 30 Months to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlanzapine

olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight

DRUGPlacebo Oral Tablet

Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine


Locations(10)

University of California

San Francisco, California, United States

The Children's Mercy Hospital

Kansas City, Missouri, United States

Columbia University/Morgan Stanley Children's Hospital

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Hospital for Sick Children

Toronto, Ontario, Canada

Centre Hospitalier Universitaire Sainte-Justine,

Montreal, Quebec, Canada

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

View Full Details on ClinicalTrials.gov

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NCT03118986


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