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IRCT20250728066668N1 IRCT 2025-08-01 Babol University of Medical Sciences Comparison Of Hypofractionated And Conventional Radiotherapy In Advanced Breast Cancer Comparison Of Local Control And Complications Of Hypofractionated Radiotherapy With Conventional In Patients With Advanced Breast Cancer 2025-08-06 anticipated 200 Complete https://irct.ir/trial/85171 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be enrolled in the study sequentially and based on the order of referral for the start of radiotherapy. Then, patients will be randomly assigned to one of the two study groups using a random number table (by the site https://www.random.org) in 1:1 blocks. An attempt will be made to ensure that patients are the same in terms of age, gender, performance level, initial stage, molecular class, and tumor location in the two groups. 3 Breast Cancer. Intervention 1: Intervention Group:Patients with advanced breast cancer undergo hypofractionated radiotherapy treatment for three weeks. During treatment, they are monitored weekly for complications based on the aforementioned criteria, and a follow-up visit is made one month after the end of treatment to check for symptoms. Intervention 2: Control group: This group of patients underwent conventional radiotherapy for five weeks according to standard treatment and were monitored weekly during treatment and then one month after treatment for the occurrence of acute symptoms. Yes - There is a plan to make this available What will be shared: The files are in Excel format and include age, treatment complications, hormone receptors, etc. and can be shared. When: 6 months after results are published To whom: This information is available to researchers working in academic and scientific institutions. Conditions: Any type of analysis on the delivered data is permitted. Where to obtain: Please Contact to the Public Accountability Officer Najme Radmard Radmardnajme1@gmail.com How to obtain: After receiving and viewing the application email and confirming the applicant, the files will be sent within a maximum of one month. Comments:
public Najme Radmard
Babol University of Medical Science, Gangafrooz St.
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 Radmardnajme1@gmail.com Babol University of Medical Sciences scientific Danial Fazilatpanah
Shahid Rajaee Hospital, Shariati St.
Babolsar Iran (Islamic Republic of) 4741999879 +98 11 3528 9259 drfazilatpanah@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) All Patients With Advanced Breast Cancer And Confirmed Histologic Diagnosis With Negative Surgical Margin 18 years 70 years Female C50 Malignant neoplasm of breast Treatment - Other Treatment - Other Intervention Group:Patients with advanced breast cancer undergo hypofractionated radiotherapy treatment for three weeks. During treatment, they are monitored weekly for complications based on the aforementioned criteria, and a follow-up visit is made one month after the end of treatment to check for symptoms. Control group: This group of patients underwent conventional radiotherapy for five weeks according to standard treatment and were monitored weekly during treatment and then one month after treatment for the occurrence of acute symptoms. Acute Complication of Hypofraction And Conventional. Timepoint: Patients will be seen weekly during radiotherapy and once a month afterwards for treatment complications. Method of measurement: A checklist designed based on CTCAE v5.0 (radiotherapy-induced dermatitis), RTOG (subcutaneous toxicity) and SOMA/LENT (telangiectasia, hand edema, pain in the radiotherapy area) will be completed to review the complications of interest. Babol University of Medical Sciences Approved 2025-04-13 Ethics committee of Babol University of Medical Sciences Babol University of Medical Sciences, Ganjafrooz St. ,Babol, Mazandaran, Iran Babol Mazandaran Iran (Islamic Republic of)