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

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

Further Study Details: 

Expected Total Enrollment:  160

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  d-MPH-COG-002
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  October 8, 2002
ClinicalTrials.gov Identifier:  NCT00047476
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08