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IRCT20200825048515N36 IRCT 2021-08-06 Esfahan University of Medical Sciences The effect of atorvastatin in the prevention of gastrointestinal toxicity in patients undergoing pelvic radiotherapy The Evaluation of the effect of atorvastatin in the prevention of gastrointestinal toxicity in patients undergoing pelvic radiotherapy 2021-08-22 anticipated 64 Complete https://irct.ir/trial/56800 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, two drugs, atorvastatin and placebo, are prepared by the pharmacist in the same shape, color. Then these are placed in coded packages and provided to the researcher, who prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention. 3 Condition 1: Gynecological cancer. Condition 2: Urological Cancer. Intervention 1: Intervention group: Patients are treated with atorvastatin at a dose of 40 mg daily from the beginning of radiotherapy to 3 months after treatment. Intervention 2: Control group: Patients are treated with placebo at a dose of 40 mg daily from the beginning of radiotherapy to 3 months after treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Simin Hemati
Radiotherapy Department, Seyed Al-Shohada Hospital,Khayyam Street.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3235 0213 Hematti@med.mui.ac.ir Esfahan University of Medical Sciences scientific Simin Hemati
Radiotherapy Department, Seyed Al-Shohada Hospital,Khayyam Street.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3235 0213 Hematti@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Pelvic radiotherapy indication due to gynecological, urological and lower gastrointestinal cancers. At least 18 years old. The total pelvic dose of patients during radiotherapy should be between 45-50 Gy. Acceptable renal function and GFR> 60 Satisfaction to participate in the study 18 years no limit Both Having a history of pelvic radiotherapy. Having diabetes due to the possibility of intestinal disorders Having an active liver or muscle disease Having the contraindications to the use of statins Having a serious physical or mental problem that prevents the completion of the course of treatment Evidence of metastasis (having a performance status score greater than 70) Taking cytochrome P450 3A4 inhibitors Unwillingness to participate in the study C57.9 C67.9 Malignant neoplasm of female genital organ, unspecified Malignant neoplasm of bladder, unspecified Treatment - Drugs Placebo Intervention group: Patients are treated with atorvastatin at a dose of 40 mg daily from the beginning of radiotherapy to 3 months after treatment. Control group: Patients are treated with placebo at a dose of 40 mg daily from the beginning of radiotherapy to 3 months after treatment. Gastrointestinal toxicity. Timepoint: Before the intervention, during the intervention, immediately after the intervention, three months after the intervention. Method of measurement: Inflammatory Bowel Disease questionnaire-bowel(IBDQ-B). Isfahan University of Medical Sciences Approved 2021-03-02 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)