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IRCT20210614051571N1 IRCT 2023-06-07 Shahre-kord University of Medical Sciences Investigating the effect of emulsion containing olive oil and calcium in reducing radiation dermatitis caused by radiotherapy in breast cancer patients The effect of olive oil and calcium hydroxide emulsion on radiation radiation-induced dermatitis in breast cancer patients referred to Adjuvant RadiationTherapy 2021-07-01 anticipated 120 Complete https://irct.ir/trial/56945 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to better manage the implementation of the experiment and the number of samples in the groups, the random block method is used. For this purpose, the eligible conditions for entering the study were assigned to groups A, B, C, and D, respectively, by random and random block method in blocks of eight people. We considered the number of samples in each block to be twice the number of groups, considering that the sample volume was equal to 120 people, for this purpose, 15 envelopes were prepared and we named them in order from number 1 to 15. Each envelope had eight identical cards. . Two cards were randomly assigned to each group and group labels with letters A, B, C and D were inserted on them. At the time of entering the study, the envelopes were opened in order and a card from abroad, the letter named on the card, showed the specific group of the patient, Blinding description: Since all the products used in the study are completely identical in terms of appearance and packaging and are inside non-transparent sprayers, and their contents are indicated by the label with English letters by the pharmacologist and using rose essence according to the pharmacologist's opinion. are the same, residents and patients do not have any information about the content inside the nebulizer. 3 Breast Cancer. Intervention 1: Control group: routine radiotherapy treatment + castor oil, which is sprayed on the target area half an hour before radiotherapy, like other groups. Intervention 2: Intervention group: Routine treatment of radiotherapy + olive oil ointment 10 mm half an hour before the start of radiotherapy for 28 sessions. Intervention 3: Intervention group: routine radiotherapy treatment + olive oil ointment with calcium hydroxide 10 mm half an hour before the start of radiotherapy for 28 sessions from Nik Darman company and with a percentage of 3%. Intervention 4: Intervention group: Routine radiotherapy treatment + castor oil ointment with calcium hydroxide 10 mm half an hour before the start of radiotherapy for 28 sessions from Nik Derman company and with a percentage of 3%. Yes - There is a plan to make this available What will be shared: Only part of the data such as information about the main outcome or the like can be shared. When: 2021-2022 To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: I have not decided yet Where to obtain: I have not decided yet How to obtain: I have not decided yet Comments:
public Reyhaneh Habibiyan
Parastar Aven.Hajar Hospital
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 St-habibiyan.r@skums.ac.ir Shahre-kord University of Medical Sciences scientific Reyhaneh Habibiyan
Parastar Aven.Hajar Hospital
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 St-habibiyan.r@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patients aged 20 to 80 years who have undergone breast tumor surgery and are indicated for adjuvant radiotherapy (both MRM and BCS) Its pathology type is invasive breastbe carcinoma Patients with a mass larger than 5 cm and at least one lymph node involved and lampooning Menopausal premenopause and postmenopausal age Do not use any other topical medication during treatment 20 years 80 years Female Diabetic patients Those with inflammatory breast carcinoma. People with known allergies to olive oil and calcium hydroxide. People with scleroderma or lung parenchymal disease. C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: routine radiotherapy treatment + castor oil, which is sprayed on the target area half an hour before radiotherapy, like other groups. Intervention group: Routine treatment of radiotherapy + olive oil ointment 10 mm half an hour before the start of radiotherapy for 28 sessions Intervention group: routine radiotherapy treatment + olive oil ointment with calcium hydroxide 10 mm half an hour before the start of radiotherapy for 28 sessions from Nik Darman company and with a percentage of 3%. Intervention group: Routine radiotherapy treatment + castor oil ointment with calcium hydroxide 10 mm half an hour before the start of radiotherapy for 28 sessions from Nik Derman company and with a percentage of 3% Radiation-induced dermatitis (erythema, dry desquamative, wet desquamative, necrosis). Timepoint: At the beginning of the study and then at the end of the first, second, third and fourth week. Method of measurement: RTOG questionnaire. Shahre-kord University of Medical Sciences Approved 2021-05-26 Ethics Committee of Shahrekord University of Medical Sciences Parastar Aven.Hajar Hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)