Methylphenidate Treatment of Cancer-Related Fatigue

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
• Treatments: Methylphenidate

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