Methylphenidate Treatment of Cancer-Related Fatigue (EMF)

January 12, 2010 updated by: Medice Arzneimittel Pütter GmbH & Co KG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
dosage according to an individual titration schedule
Active Comparator: 1
Drug: Methylphenidate hydrochloride
sustained release, dosage according to an individual titration schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life (EORTC-QLQ C30)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Investigators

  • Principal Investigator: Manfred Heim, Prof., Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6520-9959-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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