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Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue


Phase 2/Phase 3
18 Years
60 Years
Not Enrolling
Both
Cancer-related Fatigue

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Trial Information

Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Manfred Heim, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

6520-9959-02

NCT ID:

NCT00758407

Start Date:

August 2006

Completion Date:

Related Keywords:

  • Cancer-Related Fatigue
  • Fatigue, Cancer, Methylphenidate,
  • Fatigue

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