Methylphenidate Treatment of Cancer-Related Fatigue

Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue

The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.

Inclusion Criteria:

• history of Cancer
• MFI >40
• Karnofsky Index >=70
• outpatient
• patient are able to give informed consent

Exclusion Criteria:

• treatment with psychostimulants in the past two weeks before screening
• active tumor disease
• depression (HADS >10)
• cachexia (BMI <18kg/m2)
• clinically relevant kidney disorders
• clinically relevant liver disorder
• pathological ECG-finding
• high blood pressure
• occlusive arterial disease
• angina pectoris
• cardiac arrhythmias
• CHD
• post heart-attack status
• post stroke status
• known elevated intra-ocular pressure
• known enlarged prostates
• latent and manifest hyperthyreosis
• alcohol, medication or drug dependency in the past six months or manifest drug abuse
• participation in a clinical study within the past 30 days
• participation in this study at an earlier point in time
• simultaneous participation in another clinical trial
• women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
• pregnancy (positive pregnancy test) or lactation period