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

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

MedlinePlus related topics:

Cancer

ChemIDplus related topics:

Dexmethylphenidate Dexmethylphenidate hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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
	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
	Alta Bates Comprehensive Cancer Center
	Berkeley, California, United States, 94704

United States, Florida
	Cancer Research Network Inc
	Plantation, Florida, United States, 33324
	Osler Clinical Research/Osler Medical Inc
	Melbourne, Florida, United States, 32901
	University of Miami, Sylvester Cancer Research Center
	Miami, Florida, United States, 33139
	H. Lee Moffitt Cancer Center and Research Institute
	Tampa, Florida, United States, 33162
	Comprehensive Cancer Center
	Boca Raton, Florida, United States, 33428

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
	Northwest Medical Specialists, PLLC
	Tacoma, Washington, United States, 98405
	Seattle Cancer Care Alliance
	Seattle, Washington, United States, 98109-1023

United States, Wisconsin
	UW Comprehensive Cancer Center
	Madison, Wisconsin, United States, 53792-6164

Sponsors and Collaborators

Celgene Corporation

More Information

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

Keywords provided by Celgene Corporation:

neurobehavioral function

chemobrain

chemo brain

fatigue

memory loss

exhausted

trouble concentrating

Study placed in the following topic categories:

Signs and Symptoms

Fatigue

Amnesia

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on September 05, 2008

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