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Methylphenidate Treatment of Cancer-Related Fatigue (EMF)

Primary Purpose

Cancer-related Fatigue

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Methylphenidate hydrochloride
Placebo
Sponsored by
Medice Arzneimittel Pütter GmbH & Co KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Fatigue focused on measuring Fatigue, Cancer, Methylphenidate,

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonnenbergklinik
  • Praxis Dr. Lathan
  • Praxis Dr. Verpoort - Dr. Zeller
  • Dr. J.-U. Rüffer
  • Medizinische Fakultät der Universität Leipzig
  • Medizinisches Versorgungszentrum - MOP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)

Secondary Outcome Measures

Quality of Life (EORTC-QLQ C30)

Full Information

First Posted
September 24, 2008
Last Updated
January 12, 2010
Sponsor
Medice Arzneimittel Pütter GmbH & Co KG
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1. Study Identification

Unique Protocol Identification Number
NCT00758407
Brief Title
Methylphenidate Treatment of Cancer-Related Fatigue
Acronym
EMF
Official Title
Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medice Arzneimittel Pütter GmbH & Co KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Fatigue
Keywords
Fatigue, Cancer, Methylphenidate,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Methylphenidate hydrochloride
Intervention Description
sustained release, dosage according to an individual titration schedule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
dosage according to an individual titration schedule
Primary Outcome Measure Information:
Title
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Quality of Life (EORTC-QLQ C30)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Heim, Prof.
Organizational Affiliation
Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonnenbergklinik
City
Bad Sooden-Allendorf
Country
Germany
Facility Name
Praxis Dr. Lathan
City
Dortmund
Country
Germany
Facility Name
Praxis Dr. Verpoort - Dr. Zeller
City
Hamburg
Country
Germany
Facility Name
Dr. J.-U. Rüffer
City
Köln
Country
Germany
Facility Name
Medizinische Fakultät der Universität Leipzig
City
Leipzig
Country
Germany
Facility Name
Medizinisches Versorgungszentrum - MOP
City
München
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Methylphenidate Treatment of Cancer-Related Fatigue

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