Actively Recruiting
RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy
Led by The Hospital for Sick Children · Updated on 2025-10-08
200
Participants Needed
10
Research Sites
450 weeks
Total Duration
On this page
Sponsors
T
The Hospital for Sick Children
Lead Sponsor
U
University of California, San Francisco
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned receipt of highly emetogenic chemotherapy (HEC) or cyclophosphamide 61 g/m2/day (633 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning
- Plan for inpatient admission from first study drug dose until 24 hours following last study drug dose
- Body weight of at least 12.5 kg
- Age between 2.5 months and under 18 years
- Laboratory tests within one week prior to first chemotherapy or HSCT dose showing: plasma creatinine within 1.5 times the upper limit of normal for age, amylase within age-appropriate limits, plasma conjugated bilirubin 3 3x upper limit of normal for age unless Gilbert's Syndrome, ALT 4 5x upper limit of normal for age
- Baseline ECG within one month prior to study drug administration without clinically significant abnormalities including no pathologic QTc prolongation
- Scheduled, round-the-clock use of ondansetron, granisetron, or palonosetron for antiemetic prophylaxis during chemotherapy or HSCT conditioning
- Negative pregnancy test if female of childbearing potential
- Agreement to use adequate contraception or abstinence if of childbearing potential
- Parent or child able to speak a language in which the modified Pediatric Adverse Event Rating Scale (PAERS) is available
- For optional nausea severity assessment, children must be 4 to 18 years old with English, Spanish, or French speaking parent or guardian
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
University of California
San Francisco, California, United States, 94158
Actively Recruiting
2
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
3
Columbia University/Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Withdrawn
4
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7220
Actively Recruiting
5
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
6
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
7
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
8
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
9
Centre Hospitalier Universitaire Sainte-Justine,
Montreal, Quebec, Canada, H3T 1C5
Terminated
10
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
Research Team
L
Lee Dupuis, RPh, PhD
CONTACT
M
Muhammad Ali, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here