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IRCT20210819052230N1 IRCT 2022-01-29 Oroumia University of Medical Sciences Study of the efficacy of memantine in metastatic colon cance Study of the efficacy of memantine as adjunctive therapy with chemotherapy regimen in metastatic colon cancer: A pilot randomized clinical trial 2022-01-10 anticipated 50 Complete https://irct.ir/trial/60821 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, which will be allocated to 25 people in each group in a block plan, first, because there are two groups A and B, there will be 25 groups of 2, with group A being the intervention group and group B being the control group. After determining the cases, 25 cases will be selected using a random number table, and after determining the order, the list of patients will be randomly divided into two groups, Blinding description: In this study, an epidemiologist colleague will randomly divide patients into two groups, and the physician will prescribe medication for the intervention group. The participants, researcher, and data analyst are blind. 2 Metastatic colon cancer. Intervention 1: Intervention group: Standard chemotherapy drugs for colon cancer + memantine Memantine, which is our intervention, will be administered orally at a dose of 20 mg per day. Thus, in the first week, 5 mg daily and then 5 mg per week will be added and eventually continued at a dose of 20 mg per day for three months. Intervention 2: Control group: Standard chemotherapy drugs for colon cancer without prescribing memantine. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Dr. Hamid Soraya
University Campus: Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
Urmia Iran (Islamic Republic of) 5756115327 +98 44 3275 4996 hamid_soraya2000@yahoo.com Oroumia University of Medical Sciences scientific Dr. Hamid Soraya
University Campus: Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
Urmia Iran (Islamic Republic of) 5756115327 +98 44 3275 4996 hamid_soraya2000@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) All patients over 18 years of age with metastatic colon cancer 18 years no limit Both Severe renal failure Liver failure (more than 5-fold increase in liver enzymes) History of memantine allergy History of seizures Cardiovascular disease Eye diseases Concomitant use of drugs that alter the pH of the urine. C18 Malignant neoplasm of colon Treatment - Drugs Treatment - Drugs Intervention group: Standard chemotherapy drugs for colon cancer + memantine Memantine, which is our intervention, will be administered orally at a dose of 20 mg per day. Thus, in the first week, 5 mg daily and then 5 mg per week will be added and eventually continued at a dose of 20 mg per day for three months. Control group: Standard chemotherapy drugs for colon cancer without prescribing memantine Quality of life in patient with colon cancer. Timepoint: Beginning and end of the study (third month). Method of measurement: QLQ-C30 Questionnaire. The size of tumor in patients with colon cancer. Timepoint: Beginning and end of the study (third month). Method of measurement: CT scan. Vascular endothelial growth factor (VEGF). Timepoint: Beginning and end of the study (third month). Method of measurement: ELISA kit. Carcinoembryonic Antigen (CEA). Timepoint: Beginning and end of the study (third month). Method of measurement: ELISA kit. Body Mass Index (BMI). Timepoint: Beginning and end of the study (third month). Method of measurement: weight kg/height m2. Oroumia University of Medical Sciences Approved 2021-11-13 Ethics committee of Urmia University of Medical Sciences Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran Urmia West Azarbaijan Iran (Islamic Republic of)