Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents.
L Lee Dupuis, Anna Taddio, Elizabeth N Kerr...
https://pubmed.ncbi.nlm.nih.gov/16945043Actively Recruiting
Phase 2
Age: 30Months - 18Years
All Genders
ID03118986
Randomized Controlled Trial of Olanzapine for Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy
Led by The Hospital for Sick Children · Updated on 2025-10-08
200
Participants Needed
10
Research Sites
4 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
Children receiving highly emetogenic chemotherapy, including those undergoing hematopoietic stem cell transplant conditioning, often experience chemotherapy-induced nausea and vomiting (CINV) despite standard antiemetic treatments. Researchers are evaluating whether adding olanzapine to standard antiemetics can better control vomiting caused by chemotherapy in children. Olanzapine is already used safely in children with psychiatric conditions, does not interfere with chemotherapy, and is affordable. Participants will be randomly assigned to receive either olanzapine along with standard antiemetics or a placebo plus standard antiemetics. Olanzapine will be given orally once daily at 0.1 mg/kg per dose, with a maximum of 10 mg per dose, based on the child’s body weight. The study requires inpatient admission from the first dose until 24 hours after the last dose. The trial uses a triple-blind design to compare these treatments during the acute phase of chemotherapy. During the study, children will be monitored for vomiting control up to 8 days and for nausea and vomiting control up to 1 month. Safety evaluations include monitoring weight, various laboratory tests, and adverse events. The impact of olanzapine on transplant outcomes such as veno-occlusive disease and graft-versus-host disease will be assessed up to 100 days post-transplant. Participation includes scheduled antiemetic prophylaxis and assessments using validated nausea tools. The trial is expected to continue through April 2026.
CONDITIONS
Brief Title
RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy
Who Can Participate
Age: 30Months - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Planned to receive highly emetogenic chemotherapy or cyclophosphamide at or above 1 g/m2/day for cancer treatment or stem cell transplant conditioning
- Plan for hospital admission from first study drug dose until 24 hours after last dose
- Body weight of at least 12.5 kilograms
- Age between 2.5 months and under 18 years
- Laboratory tests within one week before first chemotherapy or transplant conditioning dose, including plasma creatinine, amylase, conjugated bilirubin, and ALT within specified limits
- Baseline ECG within one month before study drug without significant abnormalities
- Scheduled round-the-clock use of ondansetron, granisetron, or palonosetron for antiemetic prevention during chemotherapy or transplant 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 supported by the Pediatric Adverse Event Rating Scale
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
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Laboratory tests and baseline ECG within one month before starting treatment
Treatment
Duration - Up to 8 days
Participants receive olanzapine or placebo along with standard antiemetics during highly emetogenic chemotherapy or stem cell transplant conditioning to control chemotherapy-induced vomiting.
Daily dosing during chemotherapy with hospitalization from first dose until 24 hours after last dose
Follow-up
Duration - Up to 1 month
Participants are monitored for safety and effectiveness of olanzapine, including assessment of adverse events, weight, laboratory tests, and antiemesis scores.
Regular assessments during 1 month post-treatment
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
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Research Team
L
Lee Dupuis, RPh, PhD
M
Muhammad Ali, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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