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IRCT20240813062742N1 IRCT 2024-10-05 Yazd University of Medical Sciences Topical Erythropoietin Effectiveness for prophylaxis of radiation induced dermatitis in breast cancer patients Topical Erythropoietin Effectiveness for prophylaxis of radiation induced dermatitis in breast cancer patients 2024-10-06 anticipated 50 Complete https://irct.ir/trial/79045 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to select the sample people from the table of the random numbers, the researcher randomly starts from a point of the table in the direction of the row or column. Researcher can close her eyes and choose a point. Then based on whether the number is even or odd, the patient is given medicine A or B, Blinding description: After the cream preparement , the labels A and B are affixed by a third person and the patients, Radiation oncologist and evaluator of this outcome will be blinded to the type of the intervention. 3 Radiodermatitis. Intervention 1: Intervention group: Topical Erythropoietin cream is made by the operator in the laboratory. Patients with breast cancer referred to the center Radiation therapy is included in the study. Patients apply the cream twice a day from the first day of radiotherapy to the last day on the radiation receiving area and after two hours the area is washed. In case of grade 2 dermatitis, the drug is discontinued and the patient undergoes routine treatments. but remains in the study until the end of treatment for follow-up. Intervention 2: Control group: Placebo cream is made by the operator in the laboratory. Patients with breast cancer referred to the center Radiation therapy is included in the study. Patients apply the cream twice a day from the first day of radiotherapy to the last day on the radiation receiving area and after two hours the area is washed. In case of grade 3 dermatitis, the drug is discontinued and the patient undergoes routine treatments. but remains in the study until the end of treatment for follow-up. 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 more information
public Seyede Sahar Mesbah
No. 6 Lale Alley, Abouzar Square, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3419 sahar_mesbah@yahoo.com Yazd University of Medical Sciences scientific Fateme Saghafi
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd., Allem Square, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3725 1174 f.saghafi@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Female patients older than 18 years patients with positive histology confirm invasive and localized breast cancer Patients who candidates for adjuvant radiotherapy after surgery (breast conserving or mastectomy) Adequate literacy to fill out a consent form, understand the study, use the drug, report pain and possible side effects 18 years no limit Female Inflammatory or metastatic carcinoma Extensive skin diseases Connective tissue diseases known sensitivity to drug C50 Malignant neoplasm of breast Prevention Placebo Intervention group: Topical Erythropoietin cream is made by the operator in the laboratory. Patients with breast cancer referred to the center Radiation therapy is included in the study. Patients apply the cream twice a day from the first day of radiotherapy to the last day on the radiation receiving area and after two hours the area is washed. In case of grade 2 dermatitis, the drug is discontinued and the patient undergoes routine treatments. but remains in the study until the end of treatment for follow-up. Control group: Placebo cream is made by the operator in the laboratory. Patients with breast cancer referred to the center Radiation therapy is included in the study. Patients apply the cream twice a day from the first day of radiotherapy to the last day on the radiation receiving area and after two hours the area is washed. In case of grade 3 dermatitis, the drug is discontinued and the patient undergoes routine treatments. but remains in the study until the end of treatment for follow-up. Acute radiation dermatitis. Timepoint: Weekly during radiotherapy and two weeks after the end of radiotherapy. Method of measurement: Based on the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG / EORTC). Yazd University of Medical Sciences Approved 2023-07-16 Ethic's Committee of Shahid Sadoughi University of Medical Sciences Shahid Sadoughi University of medical Sciences, Shohadaye Gomnam Blvd, Allem square, Yazd, Iran Yazd Yazd Iran (Islamic Republic of)