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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Fatigue, Neoplasms

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

d-MPH-COG-002

NCT ID:

NCT00047476

Start Date:

June 2002

Completion Date:

March 2004

Related Keywords:

  • Fatigue
  • Neoplasms
  • neurobehavioral function
  • chemobrain
  • chemo brain
  • fatigue
  • memory loss
  • exhausted
  • trouble concentrating
  • Neoplasms
  • Fatigue

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Comprehensive Cancer Centers of the DesertPalm Springs, California  92262
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Piedmont HospitalAtlanta, Georgia  30309
Seattle Cancer Care AllianceSeattle, Washington  98109
Arizona Clinical Research CenterTucson, Arizona  85712
Cooper Green Hospital, Jefferson ClinicBirmingham, Alabama  35233
University of Alabama Palliative Care InstituteBirmingham, Alabama  35294-0023
Peak Performance WellnessFlagstaff, Arizona  86004
California Cancer Care IncGreenbrae, California  94904-2007
Clinical Trials and Research AssociatesMontebello, California  90640
Comprehensive Cancer CenterBoca Raton, Florida  33428
Osler Clinical Research/Osler Medical IncMelbourne, Florida  32901
University of Miami, Sylvester Cancer Research CenterMiami, Florida  33139
Cancer Research Network IncPlantation, Florida  33324
Markey Cancer CenterLexington, Kentucky  40536
Beth Israel Cancer CenterNew York, New York  10003
Gynecologic Oncology Associates and Development LLCGreenville, South Carolina  29604
Northwest Medical Specialists, PLLCTacoma, Washington  98405
UW Comprehensive Cancer CenterMadison, Wisconsin  53792-6164