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IRCT20181030041507N1 IRCT 2018-12-31 Shiraz University of Medical Sciences Prophylactic Effect of StrataXRT Gel on Radiation Therapy Induced Dermatitis The Investigation of Prophylactic Effect of StrataXRT Gel on Radiation Therapy Induced Dermatitis in Breast Cancer Patients. 2018-12-22 anticipated 100 Complete https://irct.ir/trial/35019 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Among patients referring to the radiation oncology department of Namazi hospital in Shiraz, who have breast cancer and undergo radical mastectomy and candidate for radiotherapy, will be randomly underwent radiation therapy, and 100 patients will be randomly placed in two main groups (StrataXRT) or control group according to randomized numbers obtaining from the website : www.random.org. 3 Radiation Induced Dermatitis in Breast Cancer. Intervention 1: Intervention group: One group of patients from the first day will use the StrataXRT gel twice daily and 5 consecutive days per week for 5-5.5 weeks on radiotherapy area, which has already been identified by the treatment planning system. Patients should wash the radiation site twice daily with water and soap, and then used StrataXRT gel on chest wall with 1-2 mm thickness, and before radiation therapy, to prevent further burns, rinse the area with water and soap. The time interval between using Strata XRT gel twice per day is six hours. this group are examined weekly and in case of second grade dermatitis, they are treated in both groups of patients. In these cases, dermatitis will be evaluated using the grading scale of acute complications according to the following table. This drug contains compounds: polidimetilsilossani,silossani,alchilmetil siliconi, and the compani is manufacturing stratpharma switzerland. Intervention 2: Control group: This group is considered as a control and it is also recommended that they daily wash the radiotherapy area, such as the intervention group and examined weekly and in case of second grade dermatitis, they are treated in the groups of patients. In these cases, dermatitis will be evaluated using the grading scale of acute complications according to the following special table. No - There is not a plan to make this available Justification or reason for not sharing IPD is No More Information.
public Zahra Eskandari
No. 216, Alawi student dormitory., 2Alley.، Mollasadra St.
Shiraz Iran (Islamic Republic of) 7193613565 +98 71 4352 3347 Z.e01365@gmail.com Shiraz University of Medical Sciences scientific Omidvari Shapoor
Hospital Namazi., Zand Street.
Shiraz Iran (Islamic Republic of) 71937-11351 +98 71 3647 4320 Omidvari@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) All patients with newly diagnosed breast cancer undergoing radical mastectomy and candidate for radiation therapy. Signing the informed consent form. No contraindication for radiotherapy. Three weeks after chemotherapy. Not receiving simultaneously chemotherapy and Herceptin. 18 years 85 years Both All patients with history of radiation therapy of breast. A history of systemic or cutaneous diseases such as diabetes mellitus or collagen vascular disease, and concomitant use of wound healing drugs such as systemic steroids. Prevention Diagnosis Intervention group: One group of patients from the first day will use the StrataXRT gel twice daily and 5 consecutive days per week for 5-5.5 weeks on radiotherapy area, which has already been identified by the treatment planning system. Patients should wash the radiation site twice daily with water and soap, and then used StrataXRT gel on chest wall with 1-2 mm thickness, and before radiation therapy, to prevent further burns, rinse the area with water and soap. The time interval between using Strata XRT gel twice per day is six hours. this group are examined weekly and in case of second grade dermatitis, they are treated in both groups of patients. In these cases, dermatitis will be evaluated using the grading scale of acute complications according to the following table. This drug contains compounds: polidimetilsilossani,silossani,alchilmetil siliconi, and the compani is manufacturing stratpharma switzerland. Control group: This group is considered as a control and it is also recommended that they daily wash the radiotherapy area, such as the intervention group and examined weekly and in case of second grade dermatitis, they are treated in the groups of patients. In these cases, dermatitis will be evaluated using the grading scale of acute complications according to the following special table. Low Grade Skin Inflammatory Changes. Timepoint: Weekly. Method of measurement: Direct Observation and Transparent Sheet. Efficacy of StrataXRT gel. Timepoint: Weekly. Method of measurement: Examining the patient's medical records. Shiraz University of Medical Sciences Approved 2018-09-30 Ethics Committee of Shiraz University of Medical Sciences No.216, Alavi Dormitory., 2 Alley., Mollasadra Street. Shiraz Fars Iran (Islamic Republic of)