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IRCT20191107045357N1 IRCT 2020-05-07 Shahid Beheshti University of Medical Sciences The efficacy of Henna cream in preventing of Radiation induced dermatitis Effect of Henna cream ( Lawsonia inermis L) in preventing and reducing the severity of Radiation induced dermatitis in patients with breast cancer 2019-11-16 anticipated 40 Complete https://irct.ir/trial/43507 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization, Blinding description: Participants, Researcher, Outcome evaluator. N/A Radiation induced dermatitis. Intervention 1: Intervention group: Cream contains 10% henna: From the beginning day of radiotherapy, patients will apply a thin layer of the cream topically to the irradiated areas, twice a day, once after treatment, and once before bedtime. Intervention 2: Control group: Placebo: Cream without pharmaceutical substance: From the beginning day of radiotherapy, patients will apply a thin layer of the cream topically to the irradiated areas, twice a day, once after treatment, and once before bedtime. Yes - There is a plan to make this available What will be shared: Personal data including demographic data and main outcome results, study protocol, data statistical analysis, Informed consent form , study report When: Three mounts after publishing results To whom: Everyone with permission Conditions: For further researches Where to obtain: mansour.stan@gmail.com Mansour Lesan How to obtain: Replying with Email Comments:
public Mansour Lesan
Radiotherapy oncology Department of Imam Hossein hospital; Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 009873432610 mansourlesan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mansour Lesan
Radiotherapy oncology Department of Imam Hossein hospital; Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 2610 mansourlesan@mail.sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with breast cancer who had breast conservative surgery 18 years 80 years Female Collagen vascular diseases Skin diseases Hypersensitivity to Henna Smoking Diabetes mellitus Chronic renal failure Concurrent chemotherapy History of chest wall irradiation History of severe reaction to topical medication Inflammatory breast cancer Radical mastectomy L58.0 Acute radiodermatitis Treatment - Drugs Treatment - Drugs Intervention group: Cream contains 10% henna: From the beginning day of radiotherapy, patients will apply a thin layer of the cream topically to the irradiated areas, twice a day, once after treatment, and once before bedtime. Control group: Placebo: Cream without pharmaceutical substance: From the beginning day of radiotherapy, patients will apply a thin layer of the cream topically to the irradiated areas, twice a day, once after treatment, and once before bedtime. Grade of dermatitis. Timepoint: Weekly during radiotherapy. Method of measurement: RTOG Grading Scale. Shahid Beheshti University of Medical Sciences Approved 2019-05-14 Ethics committe of Shahid Beheshti University of Medical Sciences School of Medicine, Shahid Beheshti University of Medical Sciences; Yaman Street Tehran Tehran Iran (Islamic Republic of)