Methylphenidate Treatment of Cancer-Related Fatigue

Phase 2

Completed

• Conditions: Cancer-related Fatigue
• Interventions: Drug: Methylphenidate hydrochloride; Drug: Placebo

• Registration Number: NCT00758407
• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Methylphenidate hydrochloride	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of Life (EORTC-QLQ C30)	6 weeks

Trial Locations

Locations (6)

Sonnenbergklinik; 🇩🇪 Bad Sooden-Allendorf, Germany

Praxis Dr. Lathan; 🇩🇪 Dortmund, Germany

Praxis Dr. Verpoort - Dr. Zeller; 🇩🇪 Hamburg, Germany

Medizinische Fakultät der Universität Leipzig; 🇩🇪 Leipzig, Germany

Dr. J.-U. Rüffer; 🇩🇪 Köln, Germany

Medizinisches Versorgungszentrum - MOP; 🇩🇪 München, Germany