Methylphenidate Treatment of Cancer-Related Fatigue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Cancer-related Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Methylphenidate hydrochloride

Intervention Type DRUG

sustained release, dosage according to an individual titration schedule

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

dosage according to an individual titration schedule

Interventions

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Methylphenidate hydrochloride

sustained release, dosage according to an individual titration schedule

Intervention Type DRUG

Placebo

dosage according to an individual titration schedule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No