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IRCT20231022059806N1 IRCT 2023-11-05 Ghoum University of Medical Sciences pregabalin effect on Oxaliplatin-induced-neuropathy Evaluation of pregabalin effect on treatment of Oxaliplatin-induced-neuropathy in patients with colorectal cancer with Folfox regime 2023-10-29 anticipated 176 Complete https://irct.ir/trial/73425 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A lottery method will be used to assign patients to two intervention and control groups. In the first stage, groups are written in the form of group A, B. Then, a lottery is drawn between the two groups to determine which is the intervention group and which is the control group, Blinding description: In this study, the data analyst and the outcome assessor will be unaware of the type of group therapy of the patients. The data in the form of questionnaires A and B will be given to the person analyzing the final data so that they are unaware of the treatment group. The outcome evaluator is not involved in the way of dividing the patients and does not know which patients have received the intervention and will only complete the questionnaire and evaluate the outcome. 3 colorectal cancer. Intervention 1: Intervention group: In addition to the main cancer treatment regimen, patients will also receive pregabalin chemotherapy at a dose of 75 mg every 12 hours for one month in the first month. Intervention 2: Control group: Patients treated with the main cancer treatment regimen will only receive it. Yes - There is a plan to make this available What will be shared: All information will be shared after de-identification. When: 6 months after the results are published. To whom: All researchers working in educational and scientific institutions. Conditions: If the information of this study is useful in collecting more extensive data. Where to obtain: Dr.Aliakbarzadeh amirqeqe@gmail.com How to obtain: After receiving the email, the data will be shared. Comments:
public Masoud Aliakbarzadeh
Shahid beheshti hospital, shahid beheshti blvd, qom
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 amirqeqe@gmail.com Ghoum University of Medical Sciences scientific Masoud Aliakbarzadeh
Shahid beheshti hospital, shahid beheshti blvd, qom
Qom Iran (Islamic Republic of) 3719964797 +98 25 3612 2000 amirqeqe@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Colorectal cancer diagnosis Age above 18 years Not using other chemotherapy regimen at the same time 18 years no limit Both Previous history of neuropathy Diagnosis of polymyositis Renal failure (GFR less than 50) Liver failure (liver enzymes more than 2-3 times normal) Diabetic patients. C19 Malignant neoplasm of rectosigmoid junction Treatment - Drugs Treatment - Drugs Intervention group: In addition to the main cancer treatment regimen, patients will also receive pregabalin chemotherapy at a dose of 75 mg every 12 hours for one month in the first month. Control group: Patients treated with the main cancer treatment regimen will only receive it. The amount of neuropathy in these patients will be measured. Timepoint: In order to check the duration of neuropathy in these patients, this questionnaire will be completed 3 months and 6 months after the end of treatment. Method of measurement: The amount of neuropathy in these patients will be measured based on a grading scale of 0 to 10. In assessing the severity of painful neuropathy based on this criterion: 0 indicates that the patient has no pain and 10 indicates the most pain that the patient has ever experienced. Ghoum University of Medical Sciences Approved 2023-03-13 Research Ethics committee of Qom University Medical Sciences Saheli St., Qom University of Medical Sciences, Qom. qom Ghoum Iran (Islamic Republic of)