Anti-Emetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting with Fosaprepitant for Children and Adolescents Receiving Moderately Emetogenic Chemotherapy: An Investigator-Initiated, Double-blinded, Superiority, Phase III Randomized Controlled Trial. - CIVIC MA

Cancer Institute (WIA)0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

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•1.Age between 4 to 18 years and diagnosed with cancer. Patients under four years have not been included as nausea assessment cannot be performed.
•2.Receiving single-day regimen of moderately emetogenic chemotherapy (MEC).
•3.Patients could have received prior chemotherapy. They need not be chemotherapy naïve.
•4.Lansky play performance score of 60 or more for less than 16 years. Eastern Cooperative Oncology Group performance status of 0, 1, or 2 for 16-18 years.
•5.Adequate organ function as confirmed by laboratory investigations within two weeks [Aspartate transaminase (AST) and Alanine transaminase (ALT) within four times upper limit of normal (ULN), serum bilirubin less than 2 mg/dL, serum creatinine within ULN].
•6.Written informed consent from parents before enrollment. Children above 7-12 years of age will need to provide verbal assent. Children between 13 and 18 years of age must provide written assent.

•1.Benzodiazepines or opioids are initiated 48 hours before treatment, except for single doses of triazolam, temazepam, or midazolam.
•2.History of vomiting 24 hours before enrollment.
•3.Use of antiemetics within 48 hours before treatment.
•4.Patients receiving corticosteroids as a part of their chemotherapy protocol.
•5.Patients with a primary brain tumor or brain metastasis.
•6.Patients receiving concurrent radiotherapy with chemotherapy.
•7.Patients in whom there are contraindications for corticosteroid use like uncontrolled diabetes mellitus, uncontrolled hypertension, active peptic ulcer disease and gastrointestinal bleeding.
•8.History of allergy to any of the drugs used for anti-emetic prophylaxis.
•9.Pregnant or breastfeeding patients.

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