Comparison between the effect of Triplet Aprepitant/Dexamethasone/Ondansetron vs. doublet Dexamethasone/Ondansetron for prevention of moderately emetogenic chemotherapy: placebo-controlled double blind, randomised clinical trial of efficacy

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 90 人开始时间: 待定最近更新: 2019年12月17日

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•Cancer patients receiving moderate emetogenic chemotherapy regimens,formed the study cohort.
•Eligible patients were adults (aged between 18 - 70 years) with a karnofsky index of 50% or more).
•Women at reproductive ages should had undertaken an appropriate contraceptive method

•causes of nausea or vomiting unrelated to the chemotherapy (e.g., gastrointestinal obstruction, massive ascites, widespread brain metastases, history of motion sickness or vestibular dysfunction, uremia or electrolyte disturbance)
•active infection
•uncontrolled seizure
•candidate for radiation therapy of brain or upper abdomen in less than a week
•an emetic episode 24 h before initiation of chemotherapy
•complications that prohibited Dexamethasone use
•one of the followings observed in their lab studies : wbc<3000/mm3 , anc<1500/m m3 , plt<100000 mm3, ALT & AST>2.5 * upper limit of normal,Bill & Cr > 1.5* upper limit of normal
•opium addicted
•poor compliance
•receiving corticosteroids for more than 3 months and more than 50 mg Prednisone daily;
•Carlson’s comorbidity scale of 3 or more
•Any drugs with antiemetic efficacy other than the study drugs wouldn’t been allowed before the study started, and were recorded on.

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