[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03118986":3,"trial-entities:NCT03118986":193,"trial-summary:NCT03118986":198},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":47,"secondary_outcomes":54,"sex":93,"minimum_age":94,"maximum_age":95,"healthy_volunteers":96,"eligibility_criteria":97,"std_ages":101,"locations":104,"central_contacts":180,"overall_officials":181,"references":187,"see_also_links":192},"NCT03118986","1000053716","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","COMPLETED","2026-06-12","2026-03","2026-08-27","2017-08-10","The Hospital for Sick Children","OTHER",true,"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",null,[19,20,21,22],"Vomiting in Infants and\u002For Children","Nausea","Hematopoietic System--Cancer","Oncology",[24,25,26,27,28,29],"olanzapine","vomiting","children","adolescents","bone marrow transplant","supportive care","INTERVENTIONAL","SUPPORTIVE_CARE",[33],"PHASE2",{"count":35,"type":36},161,"ACTUAL",[38,43],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DRUG","Olanzapine","olanzapine 0.1 mg\u002Fkg\u002Fdose (maximum 10 mg\u002Fdose) by mouth as a single daily dose based on actual body weight",[40],{"type":39,"name":44,"description":45,"armGroupLabels":46},"Placebo Oral Tablet","Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine",[44],[48,52],{"measure":49,"description":50,"timeFrame":51},"Rate of CIV control during the acute phase","Complete CIV control is no vomiting\u002Fretching and no use of breakthrough antiemetic agents during phase","up to 8 days",{"measure":49,"description":53,"timeFrame":51},"Partial control is defined as no more than two vomits or retches during any 24-hr period",[55,59,62,65,68,71,74,77,80,84,87,90],{"measure":56,"description":57,"timeFrame":58},"complete and partial CINV control","Complete CIV control is no vomiting\u002Fretching and no use of breakthrough antiemetic agents during phase, Partial control is defined as no more than two vomits or retches during any 24-hr period","up to 1 month",{"measure":60,"description":61,"timeFrame":58},"Safety profile of olanzapine based on toxicities","Based on descriptive statistics on reported toxicities.",{"measure":63,"description":64,"timeFrame":58},"Safety profile of olanzapine based on weight","Based on descriptive statistics on reported body weight",{"measure":66,"description":67,"timeFrame":58},"Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs)","Based on descriptive statistics on reported PAERs, will describe the most reported and most bothersome adverse events reported in the PAERs questionnaire.",{"measure":69,"description":70,"timeFrame":58},"Safety profile of olanzapine based on prolactin","Based on descriptive statistics on reported prolactin, will report incidence of abnormal prolactin values comparing the two arms",{"measure":72,"description":73,"timeFrame":58},"Safety profile of olanzapine based on amylase","Based on descriptive statistics on reported amylase, will report incidence of abnormal amylase values comparing the two arms",{"measure":75,"description":76,"timeFrame":58},"Safety profile of olanzapine based on creatine phophotase","Based on descriptive statistics on reported creatine phophotase, will report incidence of abnormal creatine phophotase values comparing the two arms",{"measure":78,"description":79,"timeFrame":58},"Safety profile of olanzapine based on triglycerides","Based on descriptive statistics on reported triglycerides, will report incidence of abnormal triglyceride values comparing the two arms",{"measure":81,"description":82,"timeFrame":83},"Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease","Looking at incidence of veno-occlusive disease","From first HSCT conditioning dose until 100 days post-HSCT",{"measure":85,"description":86,"timeFrame":83},"Impact of olanzapine on HSCT outcomes on incidence of GVHD","Looking at incidence of GVHD between the two arms",{"measure":88,"description":89,"timeFrame":83},"Impact of olanzapine on HSCT outcomes on severity of GVHD","Comparing the incidence of the different maximal grades of GVHD between the two arms",{"measure":91,"description":92,"timeFrame":58},"Association between PeNAT and MASCC Antiemesis Tool (MAT) scores","taking maximum daily PeNAT scale score and maximum nausea experience in MAT will estimate the degree of association between PeNAT and MAT","ALL","30 Months","18 Years",false,{"inclusion":98,"exclusion":99,"raw_text":100},[],[],"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.",[102,103],"CHILD","ADULT",[105,114,122,130,138,146,155,163,171],{"facility":106,"city":107,"state":108,"zip":109,"country":110,"geoPoint":111},"University of California","San Francisco","California","94158","United States",{"lat":112,"lon":113},37.77493,-122.41942,{"facility":115,"city":116,"state":117,"zip":118,"country":110,"geoPoint":119},"The Children's Mercy Hospital","Kansas City","Missouri","64108",{"lat":120,"lon":121},39.09973,-94.57857,{"facility":123,"city":124,"state":125,"zip":126,"country":110,"geoPoint":127},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599-7220",{"lat":128,"lon":129},35.9132,-79.05584,{"facility":131,"city":132,"state":133,"zip":134,"country":110,"geoPoint":135},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"lat":136,"lon":137},39.96118,-82.99879,{"facility":139,"city":140,"state":141,"zip":142,"country":110,"geoPoint":143},"Medical University of South Carolina","Charleston","South Carolina","29425",{"lat":144,"lon":145},32.77632,-79.93275,{"facility":147,"city":148,"state":149,"zip":150,"country":151,"geoPoint":152},"Cancer Care Manitoba","Winnipeg","Manitoba","R3E 0V9","Canada",{"lat":153,"lon":154},49.8844,-97.14704,{"facility":156,"city":157,"state":158,"zip":159,"country":151,"geoPoint":160},"Hospital for Sick Children","Toronto","Ontario","M5G 1X8",{"lat":161,"lon":162},43.70643,-79.39864,{"facility":164,"city":165,"state":166,"zip":167,"country":151,"geoPoint":168},"Centre Hospitalier Universitaire Sainte-Justine,","Montreal","Quebec","H3T 1C5",{"lat":169,"lon":170},45.50884,-73.58781,{"facility":172,"city":173,"state":174,"zip":175,"country":176,"geoPoint":177},"All India Institute of Medical Sciences","New Delhi","National Capital Territory of Delhi","110029","India",{"lat":178,"lon":179},28.62137,77.2148,[],[182,185],{"name":183,"affiliation":13,"role":184},"Lee Dupuis, RPh, PhD","PRINCIPAL_INVESTIGATOR",{"name":186,"affiliation":13,"role":184},"Muhammad Ali, MD",[188],{"pmid":189,"type":190,"citation":191},"16945043","BACKGROUND","Dupuis LL, Taddio A, Kerr EN, Kelly A, MacKeigan L. Development and validation of the pediatric nausea assessment tool for use in children receiving antineoplastic agents. Pharmacotherapy. 2006 Sep;26(9):1221-31. doi: 10.1592\u002Fphco.26.9.1221.",[],{"nct_id":4,"conditions":194,"biomarkers":197},[195,196],"Malignant Neoplasm","Vomiting",[],{"nct_id":4,"found":15,"summary":199,"prompt_version":209},{"design":200,"status":201,"heading":202,"summary":203,"follow_up":204,"word_count":205,"commitments":206,"compensation":207,"drugs_mentioned":208},"This is an interventional study involving about 200 participants. It compares olanzapine to a placebo (an inactive pill).","completed","Olanzapine for Chemotherapy-Induced Vomiting in Children","This study is testing if adding olanzapine to standard anti-nausea medications can better control vomiting caused by chemotherapy in children. Many children receiving strong chemotherapy (highly emetogenic chemotherapy, HEC) still experience vomiting despite current treatments. Olanzapine has helped adults with similar issues and has been used safely in children for other conditions. This trial will compare olanzapine to a placebo (an inactive pill that looks like olanzapine) in about 200 children aged 30 months to 18 years who are receiving HEC. The main goal is to see if olanzapine improves vomiting control during the first 8 days of chemotherapy. The study's current status is unclear.","The primary outcome measures vomiting control for up to 8 days after treatment.",105,"Not specified in the trial record.","Not stated in the trial record.",[40],"v2"]