D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
NCT ID: NCT00047476
Last Updated: 2005-06-24
Study Results
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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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2002-06-30
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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dexmethylphenidate(d-mph)
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Locations
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Cooper Green Hospital, Jefferson Clinic
Birmingham, Alabama, United States
University of Alabama Palliative Care Institute
Birmingham, Alabama, United States
Peak Performance Wellness
Flagstaff, Arizona, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
California Cancer Care Inc
Greenbrae, California, United States
Clinical Trials and Research Associates
Montebello, California, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States
Comprehensive Cancer Center
Boca Raton, Florida, United States
Osler Clinical Research/Osler Medical Inc
Melbourne, Florida, United States
University of Miami, Sylvester Cancer Research Center
Miami, Florida, United States
Cancer Research Network Inc
Plantation, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Markey Cancer Center
Lexington, Kentucky, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Beth Israel Cancer Center
New York, New York, United States
Gynecologic Oncology Associates and Development LLC
Greenville, South Carolina, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Northwest Medical Specialists, PLLC
Tacoma, Washington, United States
UW Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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d-MPH-COG-002
Identifier Type: -
Identifier Source: org_study_id
NCT00052533
Identifier Type: -
Identifier Source: nct_alias