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IRCT20150302021307N6 IRCT 2023-05-13 Ahvaz University of Medical Sciences Palliative pharmacotherapy for cancer-related fatigue 5-EPIFAT Efficacy of palliative pharmacotherapy with Methylphenidate, Bupropion, Ginseng, and Amantadine to improve fatigue in people with advanced cancer (5-EPIFAT) 2023-09-16 anticipated 255 Complete https://irct.ir/trial/69613 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 255 patients are randomly assigned to 1 of the 5 study groups using a permuted block randomization method and equal allocation ratio (51 patients in each group). The size of the blocks is randomly selected using the Blockrand package in R software (block size = 7, 14, 21, and 28), and therefore the allocation ratio is equal (1:1:1:1:1). The study statistician generate the random allocation sequence using free statistical software R. Then the statistician sends the randomization algorithm to the study pharmacist and the allocator. Each participant who has given written consent to participate in the study is uniquely identified with a two-part code. Blinded research assistants will send a randomization request to the randomization provider, who will immediately receive the order via email, and assign participants to one of 5 study groups (groups identified by a code). Participants and all study personnel (except pharmacist and allocator) are blinded to group assignment, Blinding description: The statistician sends the randomization list to the pharmacist and randomization provider. The pharmacist will not have a role in data collection and analysis. Also, the randomization provider will not play a role in the rest of the trial. Each participant who has given written consent to participate in the study is uniquely identified with a two-part code. Blinded research assistants will send a randomization request to the randomization provider, who will immediately receive the order via email, and assign participants to one of 5 study groups (groups identified by a code). Other personnel of the research team will be blind until the end of the data analysis. Also, to blind the participants and other members of the research team, the medications will be placed by the pharmacist in opaque and similar capsules in opaque and similar boxes with different coding. Medication codes and randomization list will be kept with the pharmacist until the trial is closed. 3 Cancer-related fatigue. Intervention 1: First intervention group: They will receive oral methylphenidate for 4 weeks. Methylphenidate is started at a dose of 10 mg per day in the first week. After that, the dose of 10 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 10 mg per day. Intervention 2: Second intervention group: They will receive oral bupropion for 4 weeks. Bupropion is started at a dose of 150 mg per day in the first week. After that, the dose of 150 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 150 mg per day. Intervention 3: Third intervention group: They will receive oral amantadine for 4 weeks. Amantadine is started at a dose of 100 mg per day in the first week. After that, the dose of 100 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 100 mg per day. Intervention 4: Fourth intervention group: They will receive oral ginseng for 4 weeks. Ginseng is started at a dose of 500 mg per day in the first week. After that, the dose of 500 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 500 mg per day. Intervention 5: Control group: They will receive oral placebo. Placebo will start one capsule daily in the first week. After that, two capsules per day will continue in the second and third week. After that, one capsule will be consumed again in the fourth week. Yes - There is a plan to make this available What will be shared: The data file will be subscribed to by the SPSS software format. When: The access period begins after the publication of the findings in the form of a published article. To whom: Data will be available to researchers working in the academic institutions. Conditions: Data will only be available for use in the review and meta-analysis studies. Where to obtain: Mojtaba Miladinia via academic email: miladinia.m@ajums.ac.ir How to obtain: First, send an e-mail to the author and mention the purpose of obtaining the information. In the absence of a problem, you will receive information one to three weeks later. Comments:
public Mojtaba Miladinia
School of Nursing, Ahvaz University of Medical Science, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 0000 miladinia.m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Hossein Karimpourian
School of Nursing, University of Medical Science, Golestan Blvd.
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3311 0000 karimpoorian.h@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 18 years with advanced cancer diagnosis undergoing active anticancer treatment Participants with all types of cancer except patients with central nervous system tumor or hormone-sensitive cancers or Pheochromocytoma Report of moderate to severe fatigue in the last week (score ≥ 4 on a scale of 0 to 10) Diagnosis of cancer-related fatigue based on International Classification of Diseases 10th edition (ICD-10) criteria Hemoglobin level above 9 g/dL in 2 weeks before enrollment Ability to swallow and absorb medications Females who are likely to become pregnant should use contraceptive methods during treatment and up to 6 weeks after. Ability to read and write 18 years no limit Both A known fatigue disorder not related to cancer Presence of cognitive disorders, mental disorders (severe anxiety, major depression, schizophrenia, bipolar syndrome), neurological or brain disorders (dementia, delirium, Tourette syndrome, motor tics, epilepsy, history of stroke, aneurysm) Diabetes, untreated severe anemia or anemia requiring blood transfusion, severe and uncontrolled pain and insomnia, serious cardiac disorders, uncontrolled arrhythmia or hypertension, history of long QT syndrome, glaucoma, intestinal obstruction, uncontrolled hypothyroidism, respiratory disorders limiting participation, autoimmune diseases, bleeding disorders Abnormal liver or kidney function History of a major surgery in the month before enrollment Taking erythropoietin, psychostimulants, antidepressants, nutritional supplements, or other medications to control fatigue currently or in the 4 weeks before participating in the study Simultaneous use of drugs (warfarin, anticonvulsants, tricyclic antidepressants, antipsychotics, monoamine oxidase inhibitors, clonidine, theophylline, caffeine and pseudoephedrine) Major dose change (more than 25%) of opioids within 48 hours before enrollment. Hypersensitivity to sympathomimetic amines Planned surgery within 2 months of screening History of sensitivity or intolerance to the drugs under study Pregnant or lactating women History of drug or alcohol abuse in the past year Involved in another clinical trial R53 Malaise and fatigue Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo First intervention group: They will receive oral methylphenidate for 4 weeks. Methylphenidate is started at a dose of 10 mg per day in the first week. After that, the dose of 10 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 10 mg per day. Second intervention group: They will receive oral bupropion for 4 weeks. Bupropion is started at a dose of 150 mg per day in the first week. After that, the dose of 150 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 150 mg per day. Third intervention group: They will receive oral amantadine for 4 weeks. Amantadine is started at a dose of 100 mg per day in the first week. After that, the dose of 100 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 100 mg per day. Fourth intervention group: They will receive oral ginseng for 4 weeks. Ginseng is started at a dose of 500 mg per day in the first week. After that, the dose of 500 mg twice a day is continued in the second and third week. After that, in the fourth week, the dose returns to 500 mg per day. Control group: They will receive oral placebo. Placebo will start one capsule daily in the first week. After that, two capsules per day will continue in the second and third week. After that, one capsule will be consumed again in the fourth week. Fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue scale. Timepoint: Fatigue level will be measured at baseline, weekly during the 4-week intervention period, and sixth and eighth weeks as follow-up. Totally, fatigue level will be measured for 7 times. Method of measurement: The functional assessment of chronic illness therapy-fatigue scale. To evaluate the safety, the secondary outcome is the adverse events, which will be assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. (Adverse events will be evaluated in 14 subgroups including oral, respiratory, neurological, sleep, sexual, cardio, visual, mood, cutaneous, gastrointestinal, attention, pain, genitourinary, and miscellaneous). Timepoint: Adverse events will be assessed at baseline, and weekly during the 4-week intervention period. Method of measurement: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Ahvaz University of Medical Sciences Approved 2023-03-04 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan Blvd. Ahvaz Khouzestan Iran (Islamic Republic of)