RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-18
SponsorThe Hospital for Sick Children
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 groupsSponsors 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