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

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00047476

Purpose

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

Condition	Intervention	Phase
Fatigue Neoplasms	Drug: dexmethylphenidate(d-mph)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fatigue

Drug Information available for: Dexmethylphenidate hydrochloride Dexmethylphenidate

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Estimated Enrollment:	160
Study Start Date:	June 2002
Estimated Study Completion Date:	March 2004

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047476

Locations

United States, Alabama
Cooper Green Hospital, Jefferson Clinic
Birmingham, Alabama, United States, 35233
University of Alabama Palliative Care Institute
Birmingham, Alabama, United States, 35294-0023
United States, Arizona
Peak Performance Wellness
Flagstaff, Arizona, United States, 86004
Arizona Clinical Research Center
Tucson, Arizona, United States, 85712
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
California Cancer Care Inc
Greenbrae, California, United States, 94904-2007
Clinical Trials and Research Associates
Montebello, California, United States, 90640
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States, 92262
United States, Florida
Comprehensive Cancer Center
Boca Raton, Florida, United States, 33428
Osler Clinical Research/Osler Medical Inc
Melbourne, Florida, United States, 32901
University of Miami, Sylvester Cancer Research Center
Miami, Florida, United States, 33139
Cancer Research Network Inc
Plantation, Florida, United States, 33324
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33162
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Kentucky
Markey Cancer Center
Lexington, Kentucky, United States, 40536
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, New York
Beth Israel Cancer Center
New York, New York, United States, 10003
United States, South Carolina
Gynecologic Oncology Associates and Development LLC
Greenville, South Carolina, United States, 29604
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Northwest Medical Specialists, PLLC
Tacoma, Washington, United States, 98405
United States, Wisconsin
UW Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164

Sponsors and Collaborators

Celgene Corporation

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00047476 History of Changes
Obsolete Identifiers:	NCT00052533
Other Study ID Numbers:	d-MPH-COG-002
Study First Received:	October 8, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

neurobehavioral function
chemobrain
chemo brain
fatigue

memory loss
exhausted
trouble concentrating

Additional relevant MeSH terms:

Neoplasms
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 February 09, 2012