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D-MPH in the treatment of fatigue and neurobehavioral function related to chemotherapy in adult cancer patients



D-MPH in the treatment of fatigue and neurobehavioral function related to chemotherapy in adult cancer patients

For Condition: Fatigue,Neoplasms
Status: Completed
Sponsor(s): Celgene Corporation ,
Synopsis: To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 160

Location and Contact Information:

Northwest Medical Specialists, PLLC
Tacoma,  Washington,  98405
United States
 

University of Alabama Palliative Care Institute
Birmingham,  Alabama,  35294-0023
United States
 

Cooper Green Hospital, Jefferson Clinic
Birmingham,  Alabama,  35233
United States
 

Gynecologic Oncology Associates and Development LLC
Greenville,  South Carolina,  29604
United States
 

Beth Israel Cancer Center
New York City,  New York,  10003
United States
 

Markey Cancer Center
Lexington,  Kentucky,  40536
United States
 

Sinai Hospital of Baltimore
Baltimore,  Maryland,  21215
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33162
United States
 

Peak Performance Wellness
Flagstaff,  Arizona,  86004
United States
 

California Cancer Care Inc
Greenbrae,  California,  94904-2007
United States
 

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

Comprehensive Cancer Centers of the Desert
Palm Springs,  California,  92262
United States
 

Cancer Research Network Inc
Plantation,  Florida,  33324
United States
 

Osler Clinical Research/Osler Medical Inc
Melbourne,  Florida,  32901
United States
 

Piedmont Hospital
Atlanta,  Georgia,  30309
United States
 

Clinical Trials and Research Associates
Montebello,  California,  90640
United States
 

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

Arizona Clinical Research Center
Tucson,  Arizona,  85712
United States
 

University of Miami, Sylvester Cancer Research Center
Miami,  Florida,  33139
United States
 

Comprehensive Cancer Center
Boca Raton,  Florida,  33428
United States
 

Seattle Cancer Care Alliance
Seattle,  Washington,  98109-1023
United States
 


Additional Information:
Study ID Numbers:
  d-MPH-COG-002; 
Study Start Date: June 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047476

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