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IRCT20180623040193N3 IRCT 2020-08-11 Shahre-kord University of Medical Sciences Comparison of bupropion, fluoxetine, and methylphenidate in cancer-related fatigue Comparison of the effectiveness of bupropion, fluoxetine, and methylphenidate in improving cancer-related fatigue 2020-08-22 anticipated 60 Complete https://irct.ir/trial/49183 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Given that the type of cancer may be a confounding factor, the samples are initially classified into three categories: breast cancer, gastrointestinal cancer, and other cancers. In each class, to assign samples to either the groups of fluoxetine, bupropion or methylphenidate, block randomization with a sample size of 6 is used. The sample assignment in each block is done using random allocation software, Blinding description: To contemplate blindness, the researcher who allocated the patients had no role in the treatment and the investigating physician who was responsible for the treatment of the patients was not informed about the patients’ medication. Further the patients were not aware of the nature of the allocation. 2-3 Cancer-related fatigue. Intervention 1: Intervention group: Fluoxetine 20 mg/d (Exir pharmaceutics, Iran) for the first 5 days then twice a day for the rest of the first month. In the second month, depending on the patient's tolerance, it could be increased to 40 mg/d. Intervention 2: Intervention group: Bupropion 100 mg/d (Exir pharmaceutics, Iran) with identical shape and color as fluoxetine capsules for the first five days, then twice a day for the rest of the first month. In the second month depending on the patient's tolerance, it could be increased to 300 mg/d. Intervention 3: Intervention group: Methylphenidate 10 mg/d (Poursina pharmaceutics, Iran) with identical shape and color as fluoxetine capsules for the first five days, then twice a day for the rest of the first month. In the second month depending on the patient's tolerance, it could be increased to 30 mg/d. 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 There is no more information.
public Elham Zarean
Parastar Ave, Hajar Hosp
Shahrekord Iran (Islamic Republic of) ۸۸۱۶۸۵۴۶۳۳ +98 38 3222 0016 ezarean@gmail.com Shahre-kord University of Medical Sciences scientific Elham Zarean
Parastar Ave, Hajar Hosp
Shahrekord Iran (Islamic Republic of) ۸۸۱۶۸۵۴۶۳۳ +98 38 3222 0016 ezarean@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Definite diagnosis of cancer from at least 2 month ago Patients are undergoing outpatient chemotherapy Lack of metastasis Lack of any chronic cardiac or respiratory diseases or diabetes mellitus Lack of severe bone pain and balance problem Hemoglobin≥ 10 Ability to read and write Not receiving any type of treatment (drug or psychotherapy) for fatigue in the past Not having leukemia Lack of past history of any major psychiatric illnesses for which patient was hospitalized or medicated 18 years 60 years Both Acute respiratory, cardiac or infectious diseases Hemoglobin<10 Uncontrolled hypothyroidism Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Fluoxetine 20 mg/d (Exir pharmaceutics, Iran) for the first 5 days then twice a day for the rest of the first month. In the second month, depending on the patient's tolerance, it could be increased to 40 mg/d. Intervention group: Bupropion 100 mg/d (Exir pharmaceutics, Iran) with identical shape and color as fluoxetine capsules for the first five days, then twice a day for the rest of the first month. In the second month depending on the patient's tolerance, it could be increased to 300 mg/d. Intervention group: Methylphenidate 10 mg/d (Poursina pharmaceutics, Iran) with identical shape and color as fluoxetine capsules for the first five days, then twice a day for the rest of the first month. In the second month depending on the patient's tolerance, it could be increased to 30 mg/d. Fatigue score in Cancer Fatigue scale and Fatigue Visual Analogue scale. Timepoint: Before intervention, 1 month and 2 months after pharmacotherapy. Method of measurement: Cancer Fatigue scale, Fatigue Visual Analogue scale. The Quality of life score in European Organization for Research and treatment of cancer quality of life questionnaire. Timepoint: Before intervention, 1 month and 2 months after pharmacotherapy. Method of measurement: European Organization for Research and treatment of cancer quality of life questionnaire version 3. Shahre-kord University of Medical Sciences Approved 2020-03-14 Ethics committee of Shahrekord University of Medical Sciences Kashani Ave, Shahrekord University of Medical Science Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)