Methylphenidate Treatment of Cancer-Related Fatigue

Cancer-related Fatigue Clinical Trial

— EMF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758407
• Other study ID #: 6520-9959-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 24, 2008
• Last updated: January 12, 2010
• Start date: August 2006

Study information

• Verified date: January 2010
• Source: Medice Arzneimittel Pütter GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Intervention

Drug:
• Methylphenidate hydrochloride
sustained release, dosage according to an individual titration schedule
• Placebo
dosage according to an individual titration schedule

Locations

Country	Name	City	State
Germany	Sonnenbergklinik	Bad Sooden-Allendorf
Germany	Praxis Dr. Lathan	Dortmund
Germany	Praxis Dr. Verpoort - Dr. Zeller	Hamburg
Germany	Dr. J.-U. Rüffer	Köln
Germany	Medizinische Fakultät der Universität Leipzig	Leipzig
Germany	Medizinisches Versorgungszentrum - MOP	München

Sponsors (1)

Lead Sponsor	Collaborator
Medice Arzneimittel Pütter GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)		6 weeks	No
Secondary	Quality of Life (EORTC-QLQ C30)		6 weeks	No