Anti-emetic prophylaxis for chemotherapy-induced nausea and vomiting without dexamethasone for children receiving highly emetogenic chemotherapy: investigator-initiated, open-label, phase 3 randomized controlled trial.

Cancer Institute0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

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•1.Age between 1 to 18 years and diagnosed with cancer.
•2.Receiving single-day HEC.
•3.Chemotherapy NaÃ?Â¯ve.
•4.Absence of vomiting 24 hours before enrollment.
•5.Eastern Cooperative Oncology Group performance status of 0, 1 or 2.
•6.Adequate organ function as confirmed by laboratory investigations within two weeks [Aspartate transaminase (AST) and Alanine transaminase (ALT) within 3 times upper limit of normal (ULN), serum bilirubin less than 2 mg/dL, serum creatinine within ULN].
•7.Written informed consent from parents before enrollment. Children above 7-13 years of age will need to provide verbal assent. Children between 14-18 years of age will need to provide written assent.

•1.Patients receiving steroids as part of the chemotherapy regimen or steroids are needed as pre-medication to prevent allergic reactions.
•2.Patients receiving multi-day chemotherapy in a chemotherapy block.
•3.Patients with brain metastasis.
•4.Patients receiving concurrent radiotherapy with chemotherapy.
•5.Patients in whom there are contraindications for corticosteroid use like uncontrolled diabetes mellitus, uncontrolled hypertension and active peptic ulcer disease.
•6.History of allergy to any of the drugs used for anti-emetic prophylaxis.
•7.Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days before or during the protocol therapy.
•8.Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months.
•9.History of neurological disorder including seizures and stroke within last 6 months.

发起方

Cancer Institute