[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100294904":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":35,"locations":44,"responsibleParty":187,"collaborators":190,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":25,"eligibilityCriteria":211,"healthyVolunteers":207,"sex":212,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":25,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":227,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Olanzapine","ACTIVE_COMPARATOR","Standard antiemetics plus olanzapine",[13],"Drug: Olanzapine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Oral Tablet","PLACEBO_COMPARATOR","Standard antiemetics plus placebo",[19],"Drug: Placebo Oral Tablet",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","olanzapine 0.1 mg\u002Fkg\u002Fdose (maximum 10 mg\u002Fdose) by mouth as a single daily dose based on actual body weight",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine",[15],[30,33],{"name":31,"affiliation":5,"role":32},"Lee Dupuis, RPh, PhD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":32},"Muhammad Ali, 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University",{"name":117,"class":6},{"name":201,"class":6},"CancerCare Manitoba",{"name":203,"class":6},"University of North Carolina, Chapel Hill",{"name":103,"class":6},"100294904","phase-2-rct-of-olanzapine-for-control-of-civ-in-children-receiving-highly-emetogenic-chemotherapy-100294904",false,"NCT03118986","RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy","Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Highly Emetogenic Chemotherapy","Planned receipt of HEC or cyclophosphamide ≥ 1 g\u002Fm2\u002Fday (≥ 33 mg\u002Fkg\u002Fday) for cancer treatment or autologous or allogeneic HSCT conditioning.81,82 Examples of HEC are: busulfan IV (myeloablative dosing), carboplatin ≥175mg\u002Fm²\u002Fdose, cisplatin ≥12mg\u002Fm²\u002Fdose, cytarabine ≥3g\u002Fm²\u002Fday, melphalan \\>140mg\u002Fm², methotrexate ≥12g\u002Fm²\u002Fdose and thiotepa ≥300mg\u002Fm²\u002Fdose.\n\nPlan for inpatient admission from administration of first study drug dose until 24 hours following administration of last study drug dose.\n\nBody weight of at least 12.5 kg\n\n2.5 to \\\u003C 18 years of age. Note that the minimum age requirement corresponds to an approximate body weight of 12.5 kg.\n\nSamples 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:\n\n* Plasma creatinine within 1.5 times the upper limit of normal for age.\n* Amylase within age-appropriate limits\n* Plasma conjugated bilirubin within ≤ 3x upper limit of normal for age unless attributable to Gilbert's Syndrome\n* ALT ≤ 5x upper limit of normal for age\n\nBaseline ECG within the month prior to study drug administration without known clinically significant abnormalities including pathologic prolongation of QTc\n\nA plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of chemotherapy or HSCT conditioning.\n\nNegative pregnancy test if female of childbearing potential\n\nPatients of childbearing potential must consent to use adequate contraception (males and females) or agree to practice abstinence\n\nParent or child able to speak a language in which the (modified Pediatric Adverse Event Rating Scale (PAERS) is available.\n\nOptional: Child participants in the optional assessment of nausea severity must be 4 to 18 years of age. Child and a parent\u002Fguardian 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\u002Fguardian and has been translated into Spanish and French. The MAT is available in English, Spanish and French.","ALL","30 Months","18 Years",{"count":216,"type":217},200,"ESTIMATED","INTERVENTIONAL",[220],"PHASE2","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",[223,224,225,226],"Vomiting in Infants and\u002For Children","Nausea","Hematopoietic System--Cancer","Oncology",[228,229,230,231,232,233],"olanzapine","vomiting","children","adolescents","bone marrow transplant","supportive care","2025-10-03",{"date":236,"type":237},"2025-10-08","ACTUAL",{"date":239,"type":237},"2017-08-10",{"date":241,"type":217},"2026-04",{"name":5,"class":6},10]