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IRCT20220907055912N1 IRCT 2023-02-07 Shiraz University of Medical Sciences Effect of Melatonin on radiation induced fatigue Comparison of the effectiveness of Melatonin with placebo on radiation induced fatigue in breast cancer patients 2023-02-20 anticipated 100 Complete https://irct.ir/trial/68217 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to one of the two studied groups using a random number table with 1:1 blocks. It will be tried to ensure that the patients are the same in terms of age, gender, performance level, presence of underlying disease, and level of quality of life and fatigue before the study. Medicine and placebo (which are similar to medicine in terms of shape, appearance, consistency and smell) will be placed in the same container and marked with A and B codes, Blinding description: The patient, the attending physician, as well as the person who evaluates the side effects of the treatment will be blinded to the study group; and only someone outside the research team (pharmacologist who prepares the drugs) will be aware of which group receive drug and which group receive placebo. 3 Breast cancer. Intervention 1: Intervention group: In this group, patients take two 10 mg melatonin tablets every night during radiation therapy. Melatonin drug is prepared from Jalinous pharmaceutical company. Intervention 2: Control group: In this group, patients take two placebo pills every night during radiation therapy. The placebo was prepared from Jalinous pharmaceutical company. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Sadaf Sadeghi yazdankhah
No c42, Almas shahr tower, Pezeshkan street, Moaliabad street
Shiraz Iran (Islamic Republic of) 71876-41331 +98 71 3638 0193 ssadeghiy@yahoo.com Shiraz University of Medical Sciences scientific Sadaf Sadeghi yazdankhah
No c42, Almas shahr tower, Pezeshkan street, Moaliabad street
Shiraz Iran (Islamic Republic of) 71876-41331 +98 71 3638 0193 ssadeghiy@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 18-65 years old Performance status KPS≥70 (یا ECOG score=0-1) Newly diagnosed breast cancer patient Indication of adjuant chemotherapy Indication of adjuant radiotherapy AC-T chemotherapy regimen 18 years 65 years Female Lack of consent to participate in the study Kidney, Heart and Liver chronic disease History of previous malignant disease History of previous Radiation therapy Metastasis at presentation C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients take two 10 mg melatonin tablets every night during radiation therapy. Melatonin drug is prepared from Jalinous pharmaceutical company. Control group: In this group, patients take two placebo pills every night during radiation therapy. The placebo was prepared from Jalinous pharmaceutical company. Fatigue score in MIF questionnaire and stress score in BDI. Timepoint: Before intervention and after intervention. Method of measurement: MIF fatigue measurement questionnaire, BDI-2 questionnare. Shiraz University of Medical Sciences Approved 2022-02-09 Ethics committee of Shiraz university of medical sciences Apartment c42, Almas shahr tower, Pezeshkan street, Moaliabad street Shiraz Fars Iran (Islamic Republic of)