Methylphenidate Treatment of Cancer-Related Fatigue

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00758407

Acronym

EMF

Enrollment

Registered

2008-09-25

Start date

2006-08-31

Completion date

Unknown

Last updated

2010-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer-related Fatigue

Keywords

Fatigue, Cancer, Methylphenidate,

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.

Interventions

DRUGMethylphenidate hydrochloride

sustained release, dosage according to an individual titration schedule

DRUGPlacebo

dosage according to an individual titration schedule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)	6 weeks

Secondary

Measure	Time frame
Quality of Life (EORTC-QLQ C30)	6 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026