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

Tracking Information
First Received Date ^ICMJE	October 8, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	June 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00047476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
Official Title ^ICMJE	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
Brief Summary	To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Fatigue Neoplasms
Intervention ^ICMJE	Drug: dexmethylphenidate(d-mph)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	160
Completion Date	March 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00047476
Responsible Party
Study ID Numbers ^ICMJE	d-MPH-COG-002
Study Sponsor ^ICMJE	Celgene Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Celgene Corporation
Verification Date	May 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP