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

NCT00047476 | Completed Phase 2

• 1 other identifier: d-MPH-COG-002
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 21

Brief Summary

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

Conditions

Fatigue; Neoplasms

Keywords

neurobehavioral function; chemobrain; chemo brain; fatigue; memory loss; exhausted; trouble concentrating

Interventions

dexmethylphenidate(d-mph) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (21)

Cooper Green Hospital, Jefferson Clinic

Birmingham, Alabama, 35233, United States

Location

University of Alabama Palliative Care Institute

Birmingham, Alabama, 35294-0023, United States

Location

Peak Performance Wellness

Flagstaff, Arizona, 86004, United States

Location

Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

California Cancer Care Inc

Greenbrae, California, 94904-2007, United States

Location

Clinical Trials and Research Associates

Montebello, California, 90640, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

Comprehensive Cancer Center

Boca Raton, Florida, 33428, United States

Location

Osler Clinical Research/Osler Medical Inc

Melbourne, Florida, 32901, United States

Location

University of Miami, Sylvester Cancer Research Center

Miami, Florida, 33139, United States

Location

Cancer Research Network Inc

Plantation, Florida, 33324, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33162, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Beth Israel Cancer Center

New York, New York, 10003, United States

Location

Gynecologic Oncology Associates and Development LLC

Greenville, South Carolina, 29604, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

Northwest Medical Specialists, PLLC

Tacoma, Washington, 98405, United States

Location

UW Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

Fatigue; Neoplasms; Chemotherapy-Related Cognitive Impairment; Memory Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2002
• First Posted: October 9, 2002
• Study Start: June 1, 2002
• Study Completion: March 1, 2004
• Last Updated: June 24, 2005

Record last verified: 2004-05

Locations

US (21)