Health Trials

About this trial

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 criteria

Qualifiers

Plasma creatinine within 1.5 times the upper limit of normal for age.

Amylase within age-appropriate limits

Plasma conjugated bilirubin within ≤ 3x upper limit of normal for age unless attributable to Gilbert's Syndrome

ALT ≤ 5x upper limit of normal for age

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Olanzapine
  • Placebo Oral Tablet

Treatment groups

200 Participants
are divided into 2 treatment groups

Locations

10
Canada
Cancer Care ManitobaR3E 0V9, WinnipegManitoba, Canada
Hospital for Sick ChildrenM5G 1X8, TorontoOntario, Canada
Centre Hospitalier Universitaire Sainte-Justine,H3T 1C5, MontrealQuebec, Canada
India
All India Institute of Medical Sciences110029, New DelhiNational Capital Territory of Delhi, India

Sponsors and collaborators

The Hospital for Sick Children

Lead sponsor

University of California, San Francisco

Collaborator

Children's Mercy Hospital Kansas City

Collaborator

St. Justine's Hospital

Collaborator

Columbia University

Collaborator

Medical University of South Carolina

Collaborator

CancerCare Manitoba

Collaborator

University of North Carolina, Chapel Hill

Collaborator

Nationwide Children's Hospital

Collaborator

Source ClinicalTrials.gov