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

NCT ID: NCT00047476

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-03-31

Brief Summary

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

Detailed Description

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Conditions

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Fatigue Neoplasms

Keywords

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neurobehavioral function chemobrain chemo brain fatigue memory loss exhausted trouble concentrating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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dexmethylphenidate(d-mph)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role lead

Locations

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Cooper Green Hospital, Jefferson Clinic

Birmingham, Alabama, United States

Site Status

University of Alabama Palliative Care Institute

Birmingham, Alabama, United States

Site Status

Peak Performance Wellness

Flagstaff, Arizona, United States

Site Status

Arizona Clinical Research Center

Tucson, Arizona, United States

Site Status

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

California Cancer Care Inc

Greenbrae, California, United States

Site Status

Clinical Trials and Research Associates

Montebello, California, United States

Site Status

Comprehensive Cancer Centers of the Desert

Palm Springs, California, United States

Site Status

Comprehensive Cancer Center

Boca Raton, Florida, United States

Site Status

Osler Clinical Research/Osler Medical Inc

Melbourne, Florida, United States

Site Status

University of Miami, Sylvester Cancer Research Center

Miami, Florida, United States

Site Status

Cancer Research Network Inc

Plantation, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status

Beth Israel Cancer Center

New York, New York, United States

Site Status

Gynecologic Oncology Associates and Development LLC

Greenville, South Carolina, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Northwest Medical Specialists, PLLC

Tacoma, Washington, United States

Site Status

UW Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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d-MPH-COG-002

Identifier Type: -

Identifier Source: org_study_id

NCT00052533

Identifier Type: -

Identifier Source: nct_alias