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

Information source: Celgene Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fatigue; Neoplasms

Intervention: dexmethylphenidate(d-mph) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Celgene Corporation

Summary

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

Clinical Details

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): 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.

Locations and Contacts

Cooper Green Hospital, Jefferson Clinic, Birmingham, Alabama 35233, United States

University of Alabama Palliative Care Institute, Birmingham, Alabama 35294-0023, United States

Peak Performance Wellness, Flagstaff, Arizona 86004, United States

Arizona Clinical Research Center, Tucson, Arizona 85712, United States

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

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

Piedmont Hospital, Atlanta, Georgia 30309, United States

Markey Cancer Center, Lexington, Kentucky 40536, United States

Sinai Hospital of Baltimore, Baltimore, Maryland 21215, United States

Beth Israel Cancer Center, New York, New York 10003, United States

Gynecologic Oncology Associates and Development LLC, Greenville, South Carolina 29604, United States

Northwest Medical Specialists, PLLC, Tacoma, Washington 98405, United States

Seattle Cancer Care Alliance, Seattle, Washington 98109-1023, United States

UW Comprehensive Cancer Center, Madison, Wisconsin 53792-6164, United States

Additional Information

Starting date: June 2002
Ending date: March 2004
Last updated: June 23, 2005

Page last updated: June 20, 2008

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