Study of the efficacy of memantine as adjunctive therapy with chemotherapy regimen in metastatic colon cancer: A pilot randomized clinical trial

Determining the anti-cancer effects of memantine in colon cancer

Clinical trial with control group and intervention group, double-blind, randomized, phase 2 on 50 patients. Block randomization method will be performed according to the corresponding sample size.

In this study, patients over 18 years of age with metastatic colorectal cancer referred to the subspecialty blood and oncology clinic of Imam Khomeini Hospital in Urmia who was newly diagnosed were used. After receiving conscious consent to enter the study the patients were randomly divided into two groups of 25 people equal to the standard drug treatment regimen plus memantine and the standard drug control group (control). According to the usual routine for all patients in the clinic the information about age, sex, pathology of the disease, CT scan report of the patient and concomitant diseases and initial tests will be included in the file in all patients. In patients in the first group, in addition to standard chemotherapy regimen the memantine at a dose of 20 mg per day for 3 months (starting with a daily dose of 5 mg and adding 5 mg per week and up to a maximum dose of 20 mg) was administered. The second group will be given a standard chemotherapy regimen without memantine.

All patients over 18 years of age with metastatic colon cancer that don't have severe renal failure (29-mL / min (CLcr 15 -), liver failure (more than 5-fold increase in liver enzymes), history of memantine allergy, history of seizures, cardiovascular disease, eye disease, and concomitant use of drugs that alter the pH of the urine.

two equal groups of 25 people with standard drug therapy regimen plus memantine and standard drug control group (control).

quality of life; BMI; VEGF; CEA; size of tumor

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.

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.