RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2017-08-10
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03118986

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Months to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lee Dupuis, RPh, PhD
CONTACT
416-813-7762
lee.dupuis@sickkids.ca
Muhammad Ali, MD
CONTACT
416-813-7654
muhammad.ali@sickkids.ca

Principal Investigator

Lee Dupuis, RPh, PhD
PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Muhammad Ali, MD
PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children

Study Locations (Sites)

University of California
San Francisco, California, 94158
United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Columbia University/Morgan Stanley Children's Hospital
New York, New York, 10032
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7220
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: The Hospital for Sick Children

  • Lee Dupuis, RPh, PhD, PRINCIPAL_INVESTIGATOR, The Hospital for Sick Children
  • Muhammad Ali, MD, PRINCIPAL_INVESTIGATOR, The Hospital for Sick Children

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-10
Study Completion Date2025-04

Study Record Updates

Study Start Date2017-08-10
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • olanzapine
  • vomiting
  • children
  • adolescents
  • bone marrow transplant
  • supportive care

Additional Relevant MeSH Terms

  • Vomiting in Infants and/or Children
  • Nausea
  • Hematopoietic System--Cancer
  • Oncology