NCT00758407

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

Enrollment Period

3.4 years

First QC Date

September 24, 2008

Last Update Submit

January 12, 2010

Conditions

Cancer-related Fatigue

Keywords

Fatigue, Cancer, Methylphenidate,

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Secondary Outcomes (1)

  • Quality of Life (EORTC-QLQ C30)

    6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Methylphenidate hydrochloride

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Methylphenidate hydrochlorideDRUG

sustained release, dosage according to an individual titration schedule

1
PlaceboDRUG

dosage according to an individual titration schedule

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • history of Cancer
  • MFI \>40
  • Karnofsky Index \>=70
  • outpatient
  • patient are able to give informed consent

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sonnenbergklinik

Bad Sooden-Allendorf, Germany

Location

Dr. J.-U. Rüffer

Cologne, Germany

Location

Praxis Dr. Lathan

Dortmund, Germany

Location

Praxis Dr. Verpoort - Dr. Zeller

Hamburg, Germany

Location

Medizinische Fakultät der Universität Leipzig

Leipzig, Germany

Location

Medizinisches Versorgungszentrum - MOP

München, Germany

Location

MeSH Terms

Conditions

FatigueNeoplasms

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Manfred Heim, Prof.

    Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

August 1, 2006

Primary Completion

January 1, 2010

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

DE(6)