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IRCT20120707010205N9 IRCT 2021-07-11 Babol University of Medical Sciences The effectiveness of sesame oil in breast radiotherapy burns Efficacy of sesame oil versus placebo in the management of acute radiation-induced dermatitis in breast cancer patients 2021-07-03 anticipated 40 Complete https://irct.ir/trial/57308 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this method, packages containing medicine or placebo are placed in the box as a mixture, and when offered to the candidates, without looking inside the box, one of the packages is randomly selected and given to the candidate. The package containing the placebo is marked with the letter A and the package containing the medicine is marked with the letter B, Blinding description: For blinding, sesame and paraffin oils are completely identical in terms of color, shape, consistency and smell, and are placed in the same containers so that the contents of the containers are not visible in terms of shape, color and consistency for the researcher and the patient. Somehow it is planned that the participant and the researcher They do not know which of the two control or test groups Sesame or placebo oil is given. 3 acute radiation-induced dermatitis in breast cancer patients. Intervention 1: Intervention group: Sesame oil: After each session of radiotherapy, patients should use 3 cc of sesame oil in the breast area that has undergone radiotherapy so that the solution is spread evenly on the skin surface and apply sesame oil once after each radiotherapy Continue until the end of the radiotherapy course (30 sessions). Intervention 2: Control group: Placebo paraffin: After each radiotherapy session, patients should use 3 cc of placebo in the breast area undergoing radiotherapy so that the solution is evenly distributed on the skin surface and take placebo once until the end of the radiotherapy course. (30 sessions) Continue. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dariush Muslimi
Mazandaran, Babol, Ganj Afrooz St., Babol University of Medical Sciences
Babol Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3219 9592 info@mubabol.ac.ir Babol University of Medical Sciences scientific Dr.Dariush Moslemi
Ganj afrooz Street
Babol Iran (Islamic Republic of) 4718798467 +98 11 3223 4707 d.moslemi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) All patients should complete the adjuvant chemotherapy before starting bilateral breast radiotherapy. Non-metastatic female patients with breast cancer who underwent lumpectomy Patients should be 18 to 75 years old 18 years 75 years Female Patients with collagen-vascular diseases Patients with a history of previous radiotherapy Having an active infection during the study Patients with allergies to sesame oil (or placebo) L58.9 Radiodermatitis, unspecified Treatment - Drugs Placebo Intervention group: Sesame oil: After each session of radiotherapy, patients should use 3 cc of sesame oil in the breast area that has undergone radiotherapy so that the solution is spread evenly on the skin surface and apply sesame oil once after each radiotherapy Continue until the end of the radiotherapy course (30 sessions). Control group: Placebo paraffin: After each radiotherapy session, patients should use 3 cc of placebo in the breast area undergoing radiotherapy so that the solution is evenly distributed on the skin surface and take placebo once until the end of the radiotherapy course. (30 sessions) Continue. Score of acute dermatitis according to the staging system of the Radiation Oncology Group (RTOG). Timepoint: At the beginning of the study (before the intervention) and 7, 14 and 21 and the last day after the start of sesame oil consumption. Method of measurement: RTOG criteria to evaluate acute skin reaction. Babol University of Medical Sciences Approved 2021-07-03 Babol University of Medical Sciences' Ethics Committee Ganje-Afrouz St. Babol Mazandaran Iran (Islamic Republic of)