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IRCT20211231053576N1 IRCT 2022-01-18 Shiraz University of Medical Sciences Centella asiatica extract on the prevention of radiation-induced dermatitis in breast cancer patients Comparison of the effectiveness of administration of Centella asiatica extract in comparison with placebo on the prevention of radiation-induced dermatitis in breast cancer patients 2022-02-20 anticipated 78 Complete https://irct.ir/trial/61192 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization method in the present study is simple randomization using a table of random numbers. Online tools will be used to create a random sequence. Allocation will be made using sealed envelopes, Blinding description: In this study, participants, clinician, researcher, and outcome assessor will be blind to the study groups. 2 Breast cancer. Intervention 1: Intervention group: During radiation therapy for breast cancer patients, treatment with Centella Asiatica extract (made by Nature Healing Songs Company, Tehran, Iran) will be done. Patients will be asked to apply a topical layer of ointment to the skin daily after treatment in the radiotherapy setting. Intervention 2: Control group: During radiation therapy for breast cancer patients, treatment will be performed with an ointment that is similar in consistency, odor, and color to the intervention group. Patients will be asked to apply a topical layer of ointment to the skin daily after treatment in the radiotherapy setting. Yes - There is a plan to make this available What will be shared: After the consent of the scientific officer and the approval of the ethics committee, all data is potentially shareable after unidentified individuals. When: Access period starts 6 months after the results are published To whom: Study data will be available only to researchers working in academic and scientific institutions. Conditions: The results of this study can be used for pooled meta-analysis. Where to obtain: The data can be accessed by correspondence with the scientific officer. Address: Radiation Oncology ward, Nemazee Teaching Hospital, Namazi Sq., Zand Ave. Shiraz, Fars. 7134814336. Iran Phone +98 71 3647 4332 Cellphone +98 921 165 5956 Fax +98 71 3647 4326 E-mail address mehrdadg239@gmail.com How to obtain: After the consent of the scientific officer and the approval of the ethics committee, all data is potentially shareable after unidentified individuals Comments:
public Ziba Afshari Aghajari
Namazi Hospital, Namazi Sq.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3647 4332 ziba.afshar68@gmail.com Shiraz University of Medical Sciences scientific Ziba Afshari Aghajari
Namazi Hospital, Namazi Sq.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3647 4332 ziba.afshar68@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 The Karnofsky performance scale more and equal 70 Newly diagnosed breast cancer patients Patients underwent breast conserving surgery A tumor size more than 5 centimeter in patients underwent mastectomy Regional lymph-node involvement in patients underwent mastectomy Conventional radiotherapy regimen 18 years 65 years Female Not giving consent to participate Pregnancy History of breast and chest radiation therapy History of connective tissue disease such as scleroderma or systemic lupus Distant metastasis at the presentation C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: During radiation therapy for breast cancer patients, treatment with Centella Asiatica extract (made by Nature Healing Songs Company, Tehran, Iran) will be done. Patients will be asked to apply a topical layer of ointment to the skin daily after treatment in the radiotherapy setting. Control group: During radiation therapy for breast cancer patients, treatment will be performed with an ointment that is similar in consistency, odor, and color to the intervention group. Patients will be asked to apply a topical layer of ointment to the skin daily after treatment in the radiotherapy setting. Dermatitis. Timepoint: Weekly during the intervention. Method of measurement: Physical examination. Radiotherapy leave. Timepoint: Weekly during the intervention. Method of measurement: History taking. Shiraz University of Medical Sciences Approved 2021-12-20 Ethics committee of Shiraz University of Medical Sciences Zand St., Central Building of Shiraz University of Medical Sciences, 7th Floor, Vice Chancellor for Research and Technology, Secretariat of the Research Ethics Committee Shiraz Fars Iran (Islamic Republic of)