Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy
The Hospital for Sick Children
Summary
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
- Age range
- 2–18 years
- Sex
- All
- Healthy volunteers
- No
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 corre…
Interventions
- DrugOlanzapine
olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
- DrugPlacebo Oral Tablet
Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine
Locations (10)
- University of CaliforniaSan Francisco, California
- The Children's Mercy HospitalKansas City, Missouri
- Columbia University/Morgan Stanley Children's HospitalNew York, New York
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- Nationwide Children's HospitalColumbus, Ohio
- Medical University of South CarolinaCharleston, South Carolina