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Methylphenidate Treatment of Cancer-Related Fatigue (EMF)

This study has been completed.
Sponsor:
Information provided by:
Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00758407
First received: September 24, 2008
Last updated: January 12, 2010
Last verified: January 2010
History of Changes

September 24, 2008
January 12, 2010
August 2006
January 2010   (final data collection date for primary outcome measure)
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00758407 on ClinicalTrials.gov Archive Site
Quality of Life (EORTC-QLQ C30) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Methylphenidate Treatment of Cancer-Related Fatigue
Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue

The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cancer-related Fatigue
  • Drug: Methylphenidate hydrochloride
    sustained release, dosage according to an individual titration schedule
  • Drug: Placebo
    dosage according to an individual titration schedule
  • Active Comparator: 1
    Intervention: Drug: Methylphenidate hydrochloride
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
Not Provided
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00758407
6520-9959-02
No
Dr. Armin Engels, Medical Advisor, Medice Arzneimittel Pütter GmbH & Co KG
Medice Arzneimittel Pütter GmbH & Co KG
Not Provided
Principal Investigator: Manfred Heim, Prof. Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf
Medice Arzneimittel Pütter GmbH & Co KG
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP