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IRCT20190810044500N11 IRCT 2021-03-17 Yazd University of Medical Sciences Topical Timolol Effectiveness for prophylaxy of radiation induced dermatitis in breast cancer patients Topical Timolol Effectiveness for prophylaxy of radiation induced dermatitis in breast cancer patients 2020-08-22 anticipated 64 Complete https://irct.ir/trial/46818 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: First, using Random allocation software (version 1.0), we generate a random sequence by a simple random allocation method. In this table, we specify from 1 to 64 and each number is assigned to an intervention group (A or B). The first eligible person is referred to as number 1, the second person as number 2, and so on up to 64 patients. To be blind to random allocation, patients are placed in one of the intervention groups (A or B) according to the table by a third person who is unaware of the interventions, Blinding description: After the gels 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 0.5% timolol gel 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 gel 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 gel 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 gel 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 further information.
public zahra hakimi
Professor Hesabi Blvd., Yazd Province, Yazd, Iran
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3419 zahra.hakimi1997@gmail.com Yazd University of Medical Sciences scientific Fatemeh Saghafi
Professor Hesabi Blvd., Yazd Province, Yazd, Iran
Yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۴۹ +98 35 3820 3419 F.saghafi@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Patients older than 18 years with positive histology confirm invasive and localized breast cancer, who are 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 beta-antagonist drugs C50 Malignant neoplasm of breast Prevention Placebo Intervention group:Topical 0.5% timolol gel 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 gel 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 gel 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 gel 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). Moist desquamation. Timepoint: Weekly during radiotherapy and two weeks after the end of radiotherapy. Method of measurement: Based on the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). The worst pain experienced. Timepoint: once every two weeks. Method of measurement: Based on Dermatology Life Quality Index (DLQI). Patient' skin phototype. Timepoint: Before starting radiotherapy. Method of measurement: Based on the Fitzpatrick skin phototype scale. Quality of Life. Timepoint: Before and after intervention. Method of measurement: According to the questionnaire EORTC QLQ-C30 (version 3). When the complication occurs. Timepoint: From the beginning of the intervention to two weeks after the end of radiotherapy. Method of measurement: Based on the doctor's observation and the person's statements. Yazd University of Medical Sciences Approved 2020-07-06 Ethic's Committee of Shahid Sadoughi University of Medical Sciences Professor Hesabi Blvd, Yazd Province Yazd Yazd Iran (Islamic Republic of)