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IRCT20181005041239N1 IRCT 2019-02-01 Mazandaran University of Medical Sciences The effect of radiation protection of oral atorvastatin in patients with breast cancer receiving radiotherapy Study the radioprotective effects of oral atorvastatin on side effects and effectiveness of radiotherapy in patients with breast cancer: A randomized clinical trial, evaluate of oxidative stress biomarkers and quality of life 2019-02-04 anticipated 100 Complete https://irct.ir/trial/34263 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to study. The presenter will place the envelopes containing the medication or placebo on the order of one to ninety by using random numbers. For each research sample, a research folder with the same code number or placebo code that contains all the tools for patient information will be formed. The drug envelope or placebo will be given to the research samples on the first day of the research entry. The date of the start of medication use will be noted on the envelope of medicines by label. The researcher will also remind them of the timely use of the drug by contacting the patient's telephone number. Taking a medication or placebo two weeks before the date of the first radiotherapy session will be one night, Blinding description: The supervisor will place the envelopes containing the medication or placebo on the order of 1 to 90 with random numbers. In this way, the researcher, the subjects, and the doctors and statisticians will be blind to the intervention and control group. 3 Breast cancer & Radiotherapy. Intervention 1: The intervention group: Women with breast cancer will receive radiotherapy with the standard technique of two-sided 5000CG / 25F photon tangent in the radiation center at Imam Khomeini hospital in sari. Patients are receiving the film coated tablet atorvastatin 40 mg without line per daily. Tablets manufactured by sobhan darou Pharmaceutical Company. Beginning of tablet ingestion is two weeks before radiotherapy and with the completion of radiotherapy, the tablets are consumed. Intervention 2: Control group: Women with breast cancer will receive radiotherapy with the standard technique of two-sided 5000CG / 25F photon tangent in the radiation center at Imam Khomeini hospital in sari. Patients will receive one placebo per night. Beginning of placebo ingestion is two weeks before radiotherapy and with the completion of radiotherapy, the tablets are consumed. The placebo has been produced at sari school of pharmacy under the supervision of the supervisor. No - There is not a plan to make this available Justification or reason for not sharing IPD is "No more information".
public Seyed Jalal Hosseinimehr
Sea Road, Supreme Prophet's Complex, Faculty of Pharmacy
Sari Iran (Islamic Republic of) 48471-93698 +98 11 3354 4308 sjhosseinim@mazums.ac.ir Mazandaran University of Medical Sciences scientific Seyed Jalal Hosseinimehr
Sea Road, Supreme Prophet's Complex, Faculty of Pharmacy
sari Iran (Islamic Republic of) 48471-93698 +98 11 3354 4308 sjhosseinim@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Have the ability to read and write in farsi or be able to communicate if they are illiterate. Women aged 18 and over Women with breast cancer who receive radiation dosage during treatment with the standard technique of bilateral tangent 5000CG / 25F Photon. Awareness of the person, time and place The possibility of making direct telephone calls to a patient or an active member of his family (to follow the samples) Based on bra / breast size ≤85 Women without known diseases and under medical treatmentSuch as diabetes, thyroid disorders, known liver disease, immune system weakness, rhabdomyolysis and cardiovascular disease, hyperlipidemia, depression and anxiety and taking statins with a doctor's order. Not using a psychologist or psychiatrist's counsel at the time of the study or at least a month before the study begins. 18 years no limit Female Allergy to atorvastatin Taking anti-inflammatory drugs Addicted to alcohol, cigarettes and drugs C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs The intervention group: Women with breast cancer will receive radiotherapy with the standard technique of two-sided 5000CG / 25F photon tangent in the radiation center at Imam Khomeini hospital in sari. Patients are receiving the film coated tablet atorvastatin 40 mg without line per daily. Tablets manufactured by sobhan darou Pharmaceutical Company. Beginning of tablet ingestion is two weeks before radiotherapy and with the completion of radiotherapy, the tablets are consumed. Control group: Women with breast cancer will receive radiotherapy with the standard technique of two-sided 5000CG / 25F photon tangent in the radiation center at Imam Khomeini hospital in sari. Patients will receive one placebo per night. Beginning of placebo ingestion is two weeks before radiotherapy and with the completion of radiotherapy, the tablets are consumed. The placebo has been produced at sari school of pharmacy under the supervision of the supervisor. Evaluation of skin inflammation. Timepoint: Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done. Method of measurement: radiation therapy oncology group (RTOG). Evaluation of the degree of itching,. Timepoint: Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done. Method of measurement: visual scale analog. Assessing the amount of pain. Timepoint: Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done. Method of measurement: visual scale analog. Evaluation of C reactive proteains. Timepoint: The CRP marker is measured once before the intervention and once after the completion of radiotherapy. Method of measurement: This marker is quantitatively quantified by assessing the blood serum of patients. Evaluation of oxidative stress in blood. Timepoint: Once in the first intervention and once after the completion of radiotherapy, the patient's serum is measured. Method of measurement: This marker is quantitatively quantified by assessing the blood serum of patients. Evaluation of burning rate. Timepoint: Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done. Method of measurement: visual scale analog. Evaluate the amount of edema. Timepoint: Patients will be examined for the first time before the intervention and then the end of each week until two weeks after the completion of radiotherapy, this examination will be done. Method of measurement: Self-declaration of patients and clinical examination. Quality of life. Timepoint: Before intervention radiotherapy and after the completion of radiotherapy. Method of measurement: 1. A questionnaire for quality of life for cancer patients EORTC QLQ – BR23 . 2. The quality of life of cancer patients belonging to the European Cancer Research Organization and the specific breast cancer questionnaire EORTC QLQ C-30. Mazandaran University of Medical Sciences Approved 2018-09-29 Ethics committee of Mazandaran University of Medical Sciences Moalem Ave, Moalem Squer Sari Mazandaran Iran (Islamic Republic of)