â??Olanzapine for prevention of nausea and vomiting in Children and Adolescents receiving Highly emetogenic chemotherapy (HEC): An Investigator Initiated, Randomized, Open-label Trialâ??

AIIMS0 个研究点目标入组 240 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Children and adolescents of age group 5-18 years with weight 15kg or above,
•2. All subjects must have a confirmed diagnosis of malignancy
•3. European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•4. Scheduled to receive highly emetogenic chemotherapy as assessed using the Pediatric Oncology Group of Ontario Guideline for emetogenicity Classification
•5. Patients receiving first cycle of chemotherapy
•6. Childrenâ??s caregiver who can understand Hindi or English and are willing to participate in the study (with written informed consent)

•a)Children who were treatment within 14 days prior to study enrollment with olanzapine or 30 days prior to study enrollment with another antipsychotic agent
•b)Children who are planned to receive quinolone antibiotics while receiving olanzapine
•c)Children with uncontrolled hypertension
•d)Children who are receiving other antiphychotic agents, amifostine, citalopram, CYP1A2 inducers or inhibitors
•e)Children with history of neuroleptic malignant syndrome, a seizure disorder, hypersensitivity to olanzapine.
•f)Children with known cardiac disease
•g)Pregnant or breast-feeding adolescents
•h)Children who have received or will receive RT to abdomen or pelvis in the week prior to treatment
•i)Children who had vomited in the 24 hours prior to study
•k)Children with bnormal lab values (ANC <1500/mm3, TLC <3000/mm3, Plt <100,000/mm3, AST/ALT > 2.5 times of ULN, bill >1.5 times of ULN, S.cr >1.5 times of ULN

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