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IRCT20180103038199N7 IRCT 2021-07-07 Mashhad University of Medical Sciences The effect of Saffron petal hydrogel on the prevention of radiotherapy-induced dermatitis Preparation and evaluation of the effect of hydrogel containing Saffron petal extract in prevention and reduction of severity of radiotherapy-induced acute dermatitis in breast cancer patients 2021-08-23 anticipated 80 Complete https://irct.ir/trial/57263 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization takes place in three stages: 1- Creating a random sequence: in this stage of block randomization: quadruple blocks; Possible scenarios for two groups of the experiment: Six quadruple modes including: 1- AABB, 2- ABAB, 3-BBAA, 4-BABA, 5-BAAB and 6- ABBA Possible scenarios for two groups of 40 equal to 10 = 80/4 Randomly write 20 blocks (using a table of random numbers) Write the final equivalent block Coding and allocating patients to receive medicine or placebo after opening the envelopes from number 1 to number 80, respectively. 2- Hide random allocation, which is done in the form of coded boxes with the random sequence with the help of random numbers table. In this method, a number of boxes of the same shape and size are numbered in random order and contain a medicine or placebo that have exactly the same regarding the appearance. 3- Execution of random allocation process: -The person who creates the random sequence: statistics consultant - The person who evaluates and registers the participants in terms of inclusion and exclusion criteria: Student of the project - The person who assigns the participants to the groups: Oncologist, Blinding description: Due to the use of a placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B. The placebo will be very similar in treatment in terms of shape, consistency, packaging, and smell. N/A Radiotherapy-induced mucositis is breast-conserving cancer patients. Intervention 1: Control group: Placebo hydrogel containing glycerin and green-red mixed dye made by Mashhad University of Medical Sciences. Intervention 2: Intervention group: hydrogel containing 8% Saffron petal extract and glycerin content made by Mashhad University of Medical Sciences. 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 more information
public Vahid Reza Askari
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv@mums.ac.ir Mashhad University of Medical Sciences scientific Vahid Reza Askari
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2264 askariv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Female patients diagnosed with breast tissue cancer Age over 18 years No concomitant chemotherapy No previous radiotherapy to the chest area Minimum radiation of 50 Gy during treatment BMI 20-30 Breast conserving surgery 18 years no limit Female Existence of underlying diseases hypersensitivity to Saffron petal Patients with metastatic carcinoma to the breast Inability of the patient to implement the treatment protocol L58.0, L27 Acute radiodermatitis, Localized skin eruption due to drugs and medicament Placebo Treatment - Drugs Control group: Placebo hydrogel containing glycerin and green-red mixed dye made by Mashhad University of Medical Sciences Intervention group: hydrogel containing 8% Saffron petal extract and glycerin content made by Mashhad University of Medical Sciences Incidence and severity of dermatitis. Timepoint: At the beginning of the study and every week for 6 weeks. Method of measurement: Physician evaluation checklist of incidence and severity of disease for the radiotherapy oncology group (RTOG). Quality of life. Timepoint: At the beginning and the end of the study. Method of measurement: Ware & Sherbourne's quality of life questionnaire. Mashhad University of Medical Sciences Approved 2021-06-19 Ethics committee of Mashhad University of Medical Sciences Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)