Trial | NCT00758407  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    methylphenidate ...

  • Study Participants

    66
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
Study Started
Aug 31
2006
Primary Completion
Jan 31
2010
Last Update
Jan 13
2010
Estimate

Drug Placebo

dosage according to an individual titration schedule

Drug Methylphenidate hydrochloride

sustained release, dosage according to an individual titration schedule

1 Active Comparator

2 Placebo Comparator

Criteria 

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
No Results Posted