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D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00047476
Recruitment Status : Completed
First Posted : October 9, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Celgene

Study Description
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Brief Summary:
To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.

Condition or disease Intervention/treatment Phase
Fatigue Neoplasms Drug: dexmethylphenidate(d-mph) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of d-MPH in the Treatment of Fatigue and Neurobehavioral Impairment Related to Chemotherapy in Adult Cancer Patients
Study Start Date : June 2002
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Diagnosis of cancer, excluding primary or metastatic brain tumors.
  • Treated with a minimum of four cycles of a cytotoxic chemotherapy, the last chemotherapy treatment must have been completed at least 2 months prior to study entry.
  • Physical/neurological examination consistent with the absence of a focal neurological deficit
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
  • Subjects must be able to adhere to the protocol requirements.
  • Subjects must understand and voluntarily sign an informed consent document.
  • Subjects must be a native English speaker or fluent in English, and have at least an eighth grade education.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047476


Locations
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Sponsors and Collaborators
Celgene Corporation
More Information
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ClinicalTrials.gov Identifier: NCT00047476    
Obsolete Identifiers: NCT00052533
Other Study ID Numbers: d-MPH-COG-002
First Posted: October 9, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2004
Keywords provided by Celgene:
neurobehavioral function
chemobrain
chemo brain
fatigue
 memory loss
exhausted
trouble concentrating
Additional relevant MeSH terms:
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Fatigue
Dexmethylphenidate Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents