Status:
COMPLETED
Methylphenidate Treatment of Cancer-Related Fatigue
Lead Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Conditions:
Cancer-related Fatigue
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
Eligibility Criteria
Inclusion
- history of Cancer
- MFI \>40
- Karnofsky Index \>=70
- outpatient
- patient are able to give informed consent
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00758407
Start Date
August 1 2006
Last Update
January 13 2010
Active Locations (6)
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1
Sonnenbergklinik
Bad Sooden-Allendorf, Germany
2
Dr. J.-U. Rüffer
Cologne, Germany
3
Praxis Dr. Lathan
Dortmund, Germany
4
Praxis Dr. Verpoort - Dr. Zeller
Hamburg, Germany