Palliative pharmacotherapy for cancer-related fatigue
- Conditions
- Cancer-related fatigue.Malaise and fatigue
- Registration Number
- IRCT20150302021307N6
- Lead Sponsor
- Ahvaz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 255
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.