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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Olanzapine
Drugolanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
Placebo Oral Tablet
DrugPlacebo tablets that look like olanzapine and will be dosed as if they are olanzapine
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: OlanzapineActive comparator 1 intervention
Group B: Placebo Oral TabletPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of CIV control during the acute phase
Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during phase
Time frame
up to 8 days2
Rate of CIV control during the acute phase
Partial control is defined as no more than two vomits or retches during any 24-hr period
Time frame
up to 8 daysSecondary outcomes
1
complete and partial CINV control
Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during phase, Partial control is defined as no more than two vomits or retches during any 24-hr period
Time frame
up to 1 month2
Safety profile of olanzapine based on toxicities
Based on descriptive statistics on reported toxicities.
Time frame
up to 1 month3
Safety profile of olanzapine based on weight
Based on descriptive statistics on reported body weight
Time frame
up to 1 month4
Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)
Based on descriptive statistics on reported PAERs, will describe the most reported and most bothersome adverse events reported in the PAERs questionnaire.
Time frame
up to 1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
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