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IRCT20191103045317N1 IRCT 2019-11-30 Shahid Beheshti University of Medical Sciences efficacy of adding Aprepitant into antiemesis prophylactic regimen in nausea and vomiting of moderate emetogenic regimen 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 2018-12-21 anticipated 90 Complete https://irct.ir/trial/43388 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization sequences was created using Stata10 statistical software ; using random block sizes of 4. participants stratified by a center of 1:1 allocation ,randomly assigned to either the case (Aprepitant ) or the control (placebo ) group; with equal proportion of male and female patients in each group to eliminate the confounding effect of sex, Blinding description: Patients and medical treatment team were unaware of being in case or control groups, as the drugs were coded by the pharmaceutical company, and they were decoded after the time the data were collected and analyzed. 3 Condition 1: nausea and vomiting. Condition 2: adverse reaction. Intervention 1: Intervention group: Patients were treated with triple antiemetic therapy comprising oral administration of 125 mg Aprepitant and intravenous injection of 12 mg Dexamethasone, and 8mg Ondansetron on day 1, followed by 80 mg Aprepitant on days 2 and 3. Intervention 2: Control group: received intravenous injection of 12 mg Dexamethasone, and 8mg Ondansetron on day 1, and placebo. Yes - There is a plan to make this available What will be shared: Patients' ID, sex, case or control, nausea, vomiting, complete control, complete response , overall response, resistance to treatment, When: 3 months after results publication To whom: researchers of academic and scientific centers Conditions: researching utilization of similar studies Where to obtain: contributing author: mania_008@yahoo.com How to obtain: An applying email from the named accepted centers Comments:
public Mania Rajabzadeh Kheradmardi
Jorjani center of radiation oncology, Imam Husein Hospital, Shahid Madani Ave., Nezam Abad Town
Tehran Iran (Islamic Republic of) 1617763141 00982÷77543634 mania_008@yahoo.com Shahid Beheshti University of Medical Sciences scientific Morteza Tabatabaeefar
Imam Hussein Hospital, Shahid madani Ave., Nezam Abad Town
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7754 3634 tabatabaeefar@hotmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 70 years Both 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. R11.2 T45 Nausea with vomiting, unspecified Poisoning by, adverse effect of and underdosing of primarily systemic and hematological agents, not elsewhere classified Prevention Prevention Intervention group: Patients were treated with triple antiemetic therapy comprising oral administration of 125 mg Aprepitant and intravenous injection of 12 mg Dexamethasone, and 8mg Ondansetron on day 1, followed by 80 mg Aprepitant on days 2 and 3 Control group: received intravenous injection of 12 mg Dexamethasone, and 8mg Ondansetron on day 1, and placebo Proportion of patients experiencing nausea and vomiting with MSKCC questionnaire. Timepoint: day 1 and 5 of chemotherapy. Method of measurement: MSKCC nausea and vomiting questionnaire. Complete response. Timepoint: day 1 and day 5 of chemotherapy. Method of measurement: MSKCC nausea and vomiting questionnaire. Complete control. Timepoint: day 1 and day 5 of chemotherapy. Method of measurement: MSKCC nausea and vomiting questionnaire. Overall response. Timepoint: day 1 and day 5 of chemotherapy. Method of measurement: MSKCC nausea and vomiting questionnaire. Resistance to treatment. Timepoint: day 1 and day 5 of chemotherapy. Method of measurement: MASCC nausea and vomiting questionnaire. Abidi Pharmaceutical iran Approved 2017-08-22 Ethics committee of Shahid Beheshti University of Medical Sciences Jorjani center of radiotherapy-oncology, Imam Hussein Hospital, Madani Ave., Imam Ali Blvd,.Nezan Abad Town, Tehran Tehran Iran (Islamic Republic of)