Manufacture of propranolol 3% gel and comparing it with placebo in the prevention of radiotherapy induced dermatitis in breast cancer patients; A double-blind clinical trial

investigating effect of topical propranolol 3% product in preventing radiotherapy induced dermatitis in breast cancer patients; If a topical product can reduce dermatitis in patients undergoing radiotherapy, it will be recommended as an adjunctive treatment to prevent radiotherapy-induced dermatitis.

A double-blind, placebo-controlled, randomized, phase II clinical trial on 56 patients. For randomization, a random sequence was generated using the simple random assignment method using PASS 2021 software.

Individuals will be selected to participate in the study from among those referred to Shahid Ramezanzadeh Radiation Therapy Center and will be included in the study if they consent. The blinding process will be performed for the radiation oncologist, and the treatment response evaluator. The radiotherapy dose is 50-60 Gy, given 5 days a week. Patients are told to apply a thin layer of the gel twice a day, two hours before and after radiotherapy.

inclusion criteria: People 18 years and older; Patients who have not had mastectomy surgery. Radiotherapy recipient with a maximum dose of 60 Gy in 200 cGy fractions; exclusion criteria: People with known allergies or contraindications to beta-blockers; Unwillingness to sign the consent form; Inflammatory metastatic carcinoma; Concomitant use of other antioxidant drugs; Connective tissue diseases or chronic skin disease

Patients are told to apply a thin layer of the propranolol 3% gel(intervention group) or placebo (control group) twice a day for at least two hours before and after radiotherapy.

the grade of ARD according to RTOG/EORTC and CTCAE version 5; the quality of life according to the Skindex16 (SD-16) questionnaire; the highest ARD recorded during the study; the time to the first RID.

Randomization method: Simple randomization Randomization unit: individual Randomization tool: PASS 2021 software How to create a random sequence: We generate a random sequence using the simple random assignment method. The software output is an Excel file containing a sequence of numbers from one to 56 and a unique code for the research units. Eligible individuals are numbered from 1 to 56 and assigned to an intervention group (A or B). The first eligible individual to attend is assigned number 1, the second individual is assigned number 2, and so on, up to 56 patients in the groups.

Study participants and the principal investigator and clinical outcome assessor will be blinded to this study. The gels will be delivered to the patients by a non-researcher in this study, and the patients list will remain with him/her until the end of the study.