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Completed

NCT Number: NCT00758407

Methylphenidate Treatment of 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.

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Key information

Conditions

Cancer-related Fatigue Fatigue Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sonnenbergklinik, Bad Sooden-Allendorf, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate Hydrochloride

Drug

sustained release, dosage according to an individual titration schedule

Placebo

Drug

dosage according to an individual titration schedule

Primary outcomes

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

    Time frame: 6 weeks

Secondary outcomes

  1. Quality of Life (EORTC-QLQ C30)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Industry

Registry information

Official study title

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

Acronym: EMF

Important dates

Study start
2006
Primary completion
2010
First posted
Sep 25, 2008
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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