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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
  Purpose

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


Condition Intervention Phase
Cancer-related Fatigue
Drug: Methylphenidate hydrochloride
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue

Resource links provided by NLM:


Further study details as provided by Medice Arzneimittel Pütter GmbH & Co KG:

Primary Outcome Measures:
  • General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life (EORTC-QLQ C30) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: August 2006
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Methylphenidate hydrochloride
sustained release, dosage according to an individual titration schedule
Placebo Comparator: 2 Drug: Placebo
dosage according to an individual titration schedule

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758407

Locations
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, Germany
Sponsors and Collaborators
Medice Arzneimittel Pütter GmbH & Co KG
Investigators
Principal Investigator: Manfred Heim, Prof. Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf
  More Information

No publications provided

Responsible Party: Dr. Armin Engels, Medical Advisor, Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00758407     History of Changes
Other Study ID Numbers: 6520-9959-02
Study First Received: September 24, 2008
Last Updated: January 12, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medice Arzneimittel Pütter GmbH & Co KG:
Fatigue, Cancer, Methylphenidate,

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014