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IRCT20200513047427N1 IRCT 2020-06-12 Kashan University of Medical Sciences Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial Effect of nano-curcumin on radiotherapy-induced skin reaction in breast cancer patients: a randomized, triple-blind, placebo-controlled trial 2020-06-21 anticipated 42 Complete https://irct.ir/trial/48138 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization 42 patients referred to the Yasrebi radiotherapy centre will enter the study with easy sampling. These individuals are then divided into two groups of control and treated with nano-curcumin using a mixture of 2 and 4 randomized blocks, Blinding description: Blinding is done in such a way that patients, physicians, and data analysts are unaware of the type of intervention involved, and only the person who assigns the medication and control to patients is aware of the type of treatment.Patients are blinded by taking placebo.The treating physician treats and cares for patients without knowing the type of medication.The clinician who is responsible for evaluating the outcome reports her observations without knowing which patient has taken the placebo and which patient is taking the main medication.The data analyzer also receives data as A and B. 3 Radiation induced skin reactions. Intervention 1: Intervention group: nano-curcumin Capsule (Exir Nano Sina Co.) as an 80mg gelatin capsule, one capsule per day after breakfast, from the first radiotherapy fraction to the last radiation therapy fraction. Intervention 2: Control group: No medication. Yes - There is a plan to make this available What will be shared: The documents include tables of the recovery process of patients who have used the medication. All potential data can be shared after blinding. When: Start of access period: 6 months after the publication of the results. To whom: Researchers working in academic and scientific institutions Conditions: Any kind of analysis and mechanism to improve and increase the well-being of patients and the development of science in accordance with ethical standards and protect the rights of researchers in this trial and not to distort the data. Where to obtain: Department of Medical Physics and Radiology, Faculty of Paramedical Sciences, Kashan University of Medical Sciences, Kashan, Iran Dr. Bagher Farhood, Email: bffarhood@gmail.com Tamara Talakesh, Email: tamara.talakesh@gmail.com How to obtain: The request must be sent in writing or by e-mail, and after review by the research team and the observance of ethical and legal conditions, it is agreed to send the data. Comments:
public Tamara Talakesh
No.16, 15th Ave., Mirzay -e- shirazi St.
Tehran Iran (Islamic Republic of) 1586633813 +98 21 8831 5138 tamara.talakesh@gmail.com Kashan University of Medical Sciences scientific Bagher Farhood
Pezeshk Blvd., Ghotb Ravandi Blvd.
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 8883 bffarhood@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Breast cancer patients who will undergo radiotherapy. 18 years 80 years Female Patients whose breast region have previously been irradiated. Patients with bilateral breast cancer. Patients receiving concurrent chemotherapy and radiotherapy Patients taking anticoagulants such as warfarin (Coumadin) or heparin Patients with skin conditions (such as bleeding, ulcers or incurable wounds) or sensitivity to formulations Patients treated by anti-epidermal growth factor (EGRF) Patients undergoing minor radiation to the breast area Patients with special skin allergies Patients with diagnosis of inflammatory breast cancer and reconstructive treatment L58.0 A radiation burn is damage to the skin or other biological tissue caused by exposure to radiation. The radiation types of greatest concern are thermal radiation, radio frequency energy, ultraviolet light and ionizing radiation. Prevention Other Intervention group: nano-curcumin Capsule (Exir Nano Sina Co.) as an 80mg gelatin capsule, one capsule per day after breakfast, from the first radiotherapy fraction to the last radiation therapy fraction. Control group: No medication Skin burn grade. Timepoint: Determination of skin reactionس at the beginning of the study (before the intervention), 7, 14, 21, 28 and 35 days after the start of nano-curcumin capsule consumption. Method of measurement: Determination of skin reaction (skin burn grade) according to the criteria of the Radiotherapy-Oncology group by a radiation oncologist. Kashan University of Medical Sciences Approved 2020-04-18 Ethics Committee in Research,Faculty of Nursing & Midwifery, Faculty of Health & Faculty of Paramedi 5th of Qotb –e Ravandi Blvd., Pezeshk Blvd., faculty of Nursing and Midwifery Kashan Isfehan Iran (Islamic Republic of)