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IRCT20210825052293N1 IRCT 2021-10-03 Esfahan University of Medical Sciences The effect of selenium on cancer related-fatigue Evaluation of the effect of selenium supplemention on cancer-related fatigue in outpatient cancer patients and comparison of it with placebo effect in control group 2021-10-23 anticipated 76 Complete https://irct.ir/trial/58474 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Group Allocation and Coding: In this clinical trial, the drugs (Selenium Plus and Selenium Plus without Selenium) were divided and coded into two groups, "A" and "B," by a pharmacology professor acting as the supervisor. This supervisor is also blinded to the contents of each group to prevent any potential bias. Administration of the Drugs: Neither the participants nor the researchers know which group receives which treatment. As such, the patients are unaware whether they are receiving Selenium Plus or the placebo (Selenium Plus without Selenium), and the doctors administering the treatment are similarly blinded to the type of drug being given. Data Analysis: Upon completion of the study and data collection, the statistical analysis is carried out by analysts who are also unaware of which group received the actual drug and which received the placebo. This ensures that the statistical results are free from bias. Final Unblinding: After the statistical analysis is completed, the pharmacist supervisor, who holds the group codes, reveals the information. At this stage, it is disclosed which group received Selenium Plus and which received Selenium Plus without Selenium, Blinding description: The secretary introduced the patients to the oncologist using randomized grouping and the oncologist provided treatments for each patient based on their group. The researcher, in cooperation with the oncologist, supervised the patient's use of the drug. Data available from questionnaires completed by the patients, were analyzed by a statistician specialist with respect to the confidentiality of the grouping. 3 Cancer-related fatigue. Intervention 1: Intervention Group: In this group, patients will take one 200 µg capsule of Selenium Plus once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the capsule for an additional 2 weeks, totaling 4 weeks of treatment. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 26. Intervention 2: Control Group: In this group, patients will take a placebo once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the placebo for an additional 2 weeks, totaling 4 weeks. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 26. 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 Undecided - It is not yet known if there will be a plan to make this available
public Alireza Mansouri
Dolphin 2 complex Bagh Ziar St Sohrevardi Blvd Isfahan Iran
Isfahan Iran (Islamic Republic of) 8177773095 +98 31 3776 2744 alireza.mansory@gmail.com Esfahan University of Medical Sciences scientific Dr Houriye Ansari
Hezar jarib
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8123 houri_|ansari@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 18 to 80 years of age To be able to read and write Definitive diagnosis of cancer which requires chemotherapy and has been confirmed with pathology findings and authenticated by an oncology subspecialist Not having another treatment regimen that has healing effect on fatigue To have cancer-related fatigue and score of 40 and above in fatigue questionnaire To tolerate oral medication To cooperate and agree with the study 18 years 80 years Both Patients with known depression undergoing treatment Having anemia Having a disease that prevents patient from continuing participation in study When more than 20% of the questionnaire has not been completed Pregnancy and lactation Renal failure Taking medications such as baloxavir, marboxil, deferiprone, cabotegravir, bisphosphonate derivatives, bictegravir, dolutegravir, eltrombopag, trientine, raltegravir, penicillamine, elvitegravir Known allergy to selenium Hypothyroidism Skin cancer and individulas at high risk for developing squamous cell carcinoma R53.0 Neoplasm-related fatigue Treatment - Drugs Placebo Intervention Group: In this group, patients will take one 200 µg capsule of Selenium Plus once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the capsule for an additional 2 weeks, totaling 4 weeks of treatment. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 26. Control Group: In this group, patients will take a placebo once daily for 2 weeks, after which they will complete the fatigue questionnaire. They will then continue taking the placebo for an additional 2 weeks, totaling 4 weeks. Finally, they will complete the questionnaire once more. The results will be analyzed using SPSS version 26. Cancer-related fatigue. Timepoint: Zero, 2 weeks, 4 weeks. Method of measurement: Multivariable questionnaire. Esfahan University of Medical Sciences Approved 2021-05-08 Research Ethics Committee of Isfahan University of Medical Sciences Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)