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IRCT20180222038825N1 IRCT 2018-03-28 Esfahan University of Medical Sciences The effect of topical Mometasone 0.1% and topical Hydrocortisone 1% in the prevention of acute radiation dermatitis of breast Comparison of the efficacy of topical Mometasone 0.1% and topical Hydrocortisone 1% and placebo in the prevention of acute radiation dermatitis in breast cancer patients 2017-05-05 anticipated 120 Complete https://irct.ir/trial/29925 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: randomization is simple and this will be done with statistical software SPSS 22, Blinding description: Persons who prescribe the treatment and asses the results and also the patients are blind to the given drug; so some one else will put the drugs in the packets according the random allocation list. 3 breast cancer. Intervention 1: Intervention group 1: Topical cream Mometasone 0.1%. The cream should be used once a day which is used after radiation. Also Patients will be instructed to wash skin with baby shampoo before radiation and no any cream should be on the skin. On Thursdays and Fridays that radiation will not be done, patients should use the cream on the skin once a day. This cream is manufactured by Behvazan pharmaceutics company in Iran. Intervention 2: Intervention group 2: Topical cream Hydrocortisone 1%. The cream should be used once a day which is used after radiation. Also Patients will be instructed to wash skin with baby shampoo before radiation and no any cream should be on the skin. On Thursdays and Fridays that radiation will not be done, patients should use the cream on the skin once a day. This cream is manufactured by Emad Darman Pars pharmaceutics company in Iran. Intervention 3: Control group: Base cream. The cream should be used once daily which is after radiation is done. Also Patients will be instructed to wash skin with baby shampoo before radiation and no cream should exist on the skin. On Thursdays and Fridays that radiation will not done, patients should use the cream once daily on the skin. This cream is manufactured in D.r Shahtalebi Lab in Iran. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Mahsa Kianinia
Omid hospital, Khayam St, Matahari St
Esfahan Iran (Islamic Republic of) 8184917395 +98 31 3235 0210 mahsa.kianinia@gmail.com Esfahan University of Medical Sciences scientific Mahnaz Roayaei
Omid hospital, Khayam St, Motahary St
Esfahan Iran (Islamic Republic of) 8184917395 +98 31 3235 0210 roayaei@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with breast cancer who had breast conservative surgery and should undergo breast radiation as adjuvant treatment 18 years no limit Female Past history of skin disease like eczema and psoriasis Past history of connective tissue disease like lupus erythematosus and sclerodermia recurrent or metastatic breast cancer Past radiation to the skin of treatment field C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Topical cream Mometasone 0.1%. The cream should be used once a day which is used after radiation. Also Patients will be instructed to wash skin with baby shampoo before radiation and no any cream should be on the skin. On Thursdays and Fridays that radiation will not be done, patients should use the cream on the skin once a day. This cream is manufactured by Behvazan pharmaceutics company in Iran. Intervention group 2: Topical cream Hydrocortisone 1%. The cream should be used once a day which is used after radiation. Also Patients will be instructed to wash skin with baby shampoo before radiation and no any cream should be on the skin. On Thursdays and Fridays that radiation will not be done, patients should use the cream on the skin once a day. This cream is manufactured by Emad Darman Pars pharmaceutics company in Iran. Control group: Base cream. The cream should be used once daily which is after radiation is done. Also Patients will be instructed to wash skin with baby shampoo before radiation and no cream should exist on the skin. On Thursdays and Fridays that radiation will not done, patients should use the cream once daily on the skin. This cream is manufactured in D.r Shahtalebi Lab in Iran. Radiation dermatitis grade. Timepoint: weekly after initiation of radiotherapy until the end of whole breast radiation. Method of measurement: Common Terminology Criteria for Adverse Events v4.0 (CTCAE) scale. Esfahan University of Medical Sciences Approved 2017-02-22 Ethics committee of Esfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar-Jerib Ave Esfahan Isfehan Iran (Islamic Republic of)