Methylphenidate Treatment of Cancer-Related Fatigue (EMF)

Medice Arzneimittel

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cancer-related Fatigue

Treatments

Drug: Methylphenidate hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00758407

6520-9959-02

Details and patient eligibility

About

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

Enrollment

66 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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