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IRCT20190425043368N4 IRCT 2026-05-23 Yazd University of Medical Sciences Manufacture of propranolol 3% gel and comparing it with placebo in the prevention of radiotherapy induced dermatitis in breast cancer patients 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 2026-05-24 anticipated 56 Recruiting https://irct.ir/trial/88666 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Radiotherapy induced dermatitis. Intervention 1: Intervention group: Recipient of 3% Propranolol Gel. Propranolol hydrochloride powder was obtained from Daroupakhsh Pharmaceutical Chemical Company and the gels are made weekly in the pharmaceutical laboratory of Yazd Faculty of Pharmacy. How to use the gel: Apply topically to the area to be treated 2 hours before radiation therapy, wear clothes after the gel dries. Also use 2 hours after radiation therapy.To be used throughout the entire course of radiation therapy and only on the days when radiation therapy is performed. Store in the refrigerator. Intervention 2: Control group: They receive a placebo gel, this gel does not contain propranolol hydrochloride, but in terms of other ingredients it is identical to the gel received by the intervention group. The placebo gel is also made in the pharmaceutical laboratory of the Faculty of Pharmacy of Yazd, and its use and storage method is the same as the 3% propranolol gel. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mahtabalsadat Mirjalili
School of Pharmacy, Shahid Sadoughi University of Medical Sciences Campus, Shohada-ye Gomnam Boulevard, Alem Square
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 Mahtab.mirjalili@gmail.com Yazd University of Medical Sciences scientific Mahtabalsadat Mirjalili
School of Pharmacy, Shahid Sadoughi University of Medical Sciences Campus, Shohada-ye Gomnam Boulevard, Alem Square
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 Mahtab.mirjalili@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Pathological diagnosis of breast cancer Patients who have not had their entire breast removed Radiotherapy recipient with a maximum dose of 60 Gy in 200 cGy fractions 18 years no limit Both 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 L58.0 Acute radiodermatitis Prevention Placebo Intervention group: Recipient of 3% Propranolol Gel. Propranolol hydrochloride powder was obtained from Daroupakhsh Pharmaceutical Chemical Company and the gels are made weekly in the pharmaceutical laboratory of Yazd Faculty of Pharmacy. How to use the gel: Apply topically to the area to be treated 2 hours before radiation therapy, wear clothes after the gel dries. Also use 2 hours after radiation therapy.To be used throughout the entire course of radiation therapy and only on the days when radiation therapy is performed. Store in the refrigerator. Control group: They receive a placebo gel, this gel does not contain propranolol hydrochloride, but in terms of other ingredients it is identical to the gel received by the intervention group. The placebo gel is also made in the pharmaceutical laboratory of the Faculty of Pharmacy of Yazd, and its use and storage method is the same as the 3% propranolol gel. Acute radiation dermatitis (ARD) grade. Timepoint: Weekly for up to 6 weeks. Method of measurement: Based on Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) and Common Terminology Criteria for Adverse Events (CTCAE) version 5. Yazd University of Medical Sciences Approved 2025-02-23 ethics committee of shahid sadoughi university of medical sciences School of Pharmacy, Shahid Sadoughi University of Medical Sciences Campus, Shohada-ye Gomnam Boulevard, Alem Square Yazd Yazd Iran (Islamic Republic of)