Using Olanzapine to Control Vomiting in Children Undergoing Chemotherapy
Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy
This study is testing if adding olanzapine to regular anti-nausea treatments can help children undergoing strong chemotherapy feel less sick and throw up less.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 30 Months to 18 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide |
| Locations | 10 sites (San Francisco, California and 9 other locations) |
| Trial ID | NCT03118986 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of olanzapine in controlling chemotherapy-induced vomiting (CIV) in children receiving highly emetogenic chemotherapy. The study aims to determine if adding olanzapine to standard antiemetic treatments can improve the management of nausea and vomiting during cancer treatment. Participants will be children aged 2.5 to 18 years who are scheduled to receive specific high-dose chemotherapy regimens or hematopoietic stem cell transplants. The trial will involve a comparison between olanzapine and a placebo to assess its impact on vomiting control.
Who should consider this trial
Good fit: Ideal candidates are children aged 2.5 to 18 years who are receiving highly emetogenic chemotherapy or undergoing hematopoietic stem cell transplantation.
Not a fit: Patients who are not undergoing highly emetogenic chemotherapy or do not meet the weight and age criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for children undergoing chemotherapy by reducing nausea and vomiting.
How similar studies have performed: Previous studies have shown that olanzapine can effectively control nausea and vomiting in adult cancer patients, suggesting potential success in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Planned receipt of HEC or cyclophosphamide ≥ 1 g/m2/day (≥ 33 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning.81,82 Examples of HEC are: busulfan IV (myeloablative dosing), carboplatin ≥175mg/m²/dose, cisplatin ≥12mg/m²/dose, cytarabine ≥3g/m²/day, melphalan \>140mg/m², methotrexate ≥12g/m²/dose and thiotepa ≥300mg/m²/dose. Plan for inpatient admission from administration of first study drug dose until 24 hours following administration of last study drug dose. Body weight of at least 12.5 kg 2.5 to \< 18 years of age. Note that the minimum age requirement corresponds to an approximate body weight of 12.5 kg. Samples for all laboratory tests will be obtained within one week prior to administration of the first chemotherapy dose of the study chemotherapy block or the first HSCT conditioning dose: * 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 Baseline ECG within the month prior to study drug administration without known clinically significant abnormalities including pathologic prolongation of QTc A plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of chemotherapy or HSCT conditioning. Negative pregnancy test if female of childbearing potential Patients of childbearing potential must consent to use adequate contraception (males and females) or agree to practice abstinence Parent or child able to speak a language in which the (modified Pediatric Adverse Event Rating Scale (PAERS) is available. Optional: Child participants in the optional assessment of nausea severity must be 4 to 18 years of age. Child and a parent/guardian must be English, Spanish or French-speaking. The Pediatric Nausea Assessment Tool58 (PeNAT) is validated in English-speaking children 4 to 18 years old with an English-speaking parent/guardian and has been translated into Spanish and French. The MAT is available in English, Spanish and French.
Where this trial is running
San Francisco, California and 9 other locations
- University of California — San Francisco, California, United States (Recruiting)
- The Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
- Columbia University/Morgan Stanley Children's Hospital — New York, New York, United States (Withdrawn)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Cancer Care Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
- Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
- Centre Hospitalier Universitaire Sainte-Justine, — Montreal, Quebec, Canada (Terminated)
- All India Institute of Medical Sciences — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Principal investigator: Lee Dupuis, RPh, PhD — The Hospital for Sick Children
- Study coordinator: Lee Dupuis, RPh, PhD
- Email: lee.dupuis@sickkids.ca
- Phone: 416-813-7762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.