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

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

This study has been completed.

Study NCT00047476. Last updated on June 23, 2005. Information provided by Celgene Corporation

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
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
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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Fatigue Neoplasms
Intervention ^†	Drug: dexmethylphenidate(d-mph)
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	160
Start Date ^†	June 2002
Completion Date	March 2004
Eligibility 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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00047476
Organization ID	d-MPH-COG-002
Secondary IDs ^††
Study Sponsor ^†	Celgene Corporation
Collaborators ^††
Investigators ^†
Information Provided By	Celgene Corporation
Verification Date	May 2004
First Received Date ^†	October 8, 2002
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.