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IRCT20090813002342N7 IRCT 2018-08-08 Mazandaran University of Medical Sciences Effectiveness of Black cumin gel in radio-dermatitis in breast cancer Effectiveness and safety of 5% gel of extract of Nigella sativa L. to prevent radio-dermatitis in breast cancer patients 2018-07-23 anticipated 60 Complete https://irct.ir/trial/32949 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be treated with 5% Nigella sativa gel and placebo gel using the blocking method. The generation of random numbers is done with Random allocation software, and 60 samples will be assigned in 6 blocks of 10. All products used in the study are completely identical in terms of appearance and packaging, and their content will be characterized by a four-digit code, Blinding description: Since all the products used in the study are completely identical in terms of appearance and packaging and their content is characterized by a four-digit code, patients do not have any information about their treatment group. Also, the patient's treatment group is determined randomly, according to the previously defined coding. Only the secretary of radiotherapy ward who offers the product to the patients knows the treatment groups of the patients. Clinical caregiver (physician), researcher and evaluator of the outcome (researcher) have no information on the treatment group of patients. 3 radiodermatitis. Intervention 1: Intervention group: 5% gel of black seed extract. Intervention 2: Control group: Placebo gel. 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 No more information
public Mohammad Raza Rafati
School of Pharmacy, Mazandran University of Medical Sciences, 18, Khazar Abad Road
Sari Iran (Islamic Republic of) 48175-1553 +98 11 3354 3243 mrrafati@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mohammad Reza Rafati
School of Pharmacy, Mazandran University of Medical Sciences, 18, Khazar Abad Road
Sari Iran (Islamic Republic of) 48175-1553 +98 11 3354 3243 mrrafati@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Confirmed histological diagnosis of ductal or lobular breast Carcinoma Adjuvant radiotherapy after surgery 18 years no limit Female Patients with previous radiotherapy to the chest or breast Patients with concomitant adjuvant or neoadjuvant chemotherapy Generalized skin or connective tissue disorders Unhealed surgical wounds A known allergy to Black cumin or any excipient of gel formulation L58 Radiodermatitis Treatment - Drugs Treatment - Drugs Intervention group: 5% gel of black seed extract Control group: Placebo gel The time of incidence of radio-dermatitis. Timepoint: At the beginning of the study (before the intervention) and weekly until the end of the radiotherapy period. Method of measurement: Radiation therapy oncology group (RTOG) و National Cancer institute: Common Terminology Criteria for Adverse Events v5.0 (CTCAE) Scales. The quality of life of patients. Timepoint: Biweekly after initiation of radiotherapy period. Method of measurement: Dermatology Life Quality Index (DLQI) questionnaire. Mazandaran University of Medical Sciences Approved 2018-07-11 Ethics Committee of Mazandaran University of Medical Sciences Vice-Chancellor for Research of Mazandaran University of Medical Sciences, Moallem Square Sari Mazandaran Iran (Islamic Republic of)