Methylphenidate Treatment of Cancer-Related Fatigue (EMF)
This study has been completed.
Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Information provided by:
Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00758407
First received: September 24, 2008
Last updated: January 12, 2010
Last verified: January 2010
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Purpose
The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer-related Fatigue |
Drug: Methylphenidate hydrochloride Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue |
Resource links provided by NLM:
Further study details as provided by Medice Arzneimittel Pütter GmbH & Co KG:
Primary Outcome Measures:
- General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life (EORTC-QLQ C30) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | August 2006 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Methylphenidate hydrochloride
sustained release, dosage according to an individual titration schedule
|
| Placebo Comparator: 2 |
Drug: Placebo
dosage according to an individual titration schedule
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758407
Locations
| Germany | |
| Sonnenbergklinik | |
| Bad Sooden-Allendorf, Germany | |
| Praxis Dr. Lathan | |
| Dortmund, Germany | |
| Praxis Dr. Verpoort - Dr. Zeller | |
| Hamburg, Germany | |
| Dr. J.-U. Rüffer | |
| Köln, Germany | |
| Medizinische Fakultät der Universität Leipzig | |
| Leipzig, Germany | |
| Medizinisches Versorgungszentrum - MOP | |
| München, Germany | |
Sponsors and Collaborators
Medice Arzneimittel Pütter GmbH & Co KG
Investigators
| Principal Investigator: | Manfred Heim, Prof. | Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf |
More Information
No publications provided
| Responsible Party: | Dr. Armin Engels, Medical Advisor, Medice Arzneimittel Pütter GmbH & Co KG |
| ClinicalTrials.gov Identifier: | NCT00758407 History of Changes |
| Other Study ID Numbers: | 6520-9959-02 |
| Study First Received: | September 24, 2008 |
| Last Updated: | January 12, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Medice Arzneimittel Pütter GmbH & Co KG:
|
Fatigue, Cancer, Methylphenidate, |
Additional relevant MeSH terms:
|
Fatigue Signs and Symptoms Methylphenidate Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013