None listed
Conditions
Brief summary
Objectives: A) To determine a population estimate of the efficacy of Mehtylphenidate in alleviating fatigue in patients with advanced cancer. B) To provide process evaluation on the feasibility of Single Patient Trials as a routine means of conducting clinical trials in palliative care. C) To develop, employ and recommend appropriate statistical techniques for the analysis of Single Patient Trial data derived from patients with advanced cancer; specifically, to develop and evaluate a method that estimates the effect of patient deterioration over the conduct of clinical trials and, where appropriate, provides a means of adjusting for illness progression.
Interventions
Methylphendiate -In single patient trials each patient undergoes 3 pairs of treatment periods. Each treatment period is 3 days (thus each pair is 6 days). The order of Methylphenidate and placebo will be determined by random allocation, blinded to both clinician and patient. The dose will be 5mg bi-daily (oral capsules). The drug will be capsules administered bi-daily by the patient. The drug and placebo will be packaged for patients ease of use. Methylphenidate has a short half life, so the
Methylphendiate -In single patient trials each patient undergoes 3 pairs of treatment periods. Each treatment period is 3 days (thus each pair is 6 days). The order of Methylphenidate and placebo will be determined by random allocation, blinded to both clinician and patient. The dose will be 5mg bi-daily (oral capsules). The drug will be capsules administered bi-daily by the patient. The drug and placebo will be packaged for patients ease of use. Methylphenidate has a short half life, so there is no wash out period between pairs. The data from the first of each 3 day period will be removed from analysis in case of any carry over effect of the drug. The intervention will be a total of 18 days.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with advanced cancer 2. = 18 years of age. 3. Australia-modifed Karnofsky Performance Status (AKPS) score of ?40. 4. Fatigue score ? 4/10 on screening for fatigue using a single screening questionnaire adopted from the National Comprehensive Cancer Network (NCCN) cancer-related fatigue guidelines. (7) 5. Treatment regimen (including steroids) stable for at least 48 hours and likely to remain stable throughout the trial period. 6. No treatment likely to influence fatigue during the course of the clinical trial (examples will be presented in operational procedures) 7. No change in thyroxine therapy or antidepressant therapy for the 3 weeks prior to study. 8. Ability to understand and conform to all study requirements
Exclusion criteria
1. Unable to comprehend written English. 2. Confusion or Mini-Mental State Examination < 24 3. Unstable symptoms or disease such that the patient is unlikely to be able to complete all study requirement over the 2 week study period 4. History of severe ischaemic heart disease 5. Uncontrolled cardiac arrhythmias or hypertension 6. Electrolyte imbalances (Na, K, Mg, Ca) where attempt at correction would be appropriate. 7. Anemia for which a blood transfusion is indicated as a treatment for fatigue 8. Erythropoietin therapy in the 2 weeks prior to study.
Outcome results
None listed