Cancer-related fatigue. Malaise and fatigue
Conditions
Interventions
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 twi
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMojtaba Miladinia
Ahvaz University of Medical Sciences
Outcome results
None listed