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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047476
• Other study ID #: d-MPH-COG-002
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2002
• Last updated: June 23, 2005
• Start date: June 2002
• Est. completion date: March 2004

Study information

• Verified date: May 2004
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00052533

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Neoplasms

Intervention

Drug:
• dexmethylphenidate(d-mph)

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Cooper Green Hospital, Jefferson Clinic	Birmingham	Alabama
United States	University of Alabama Palliative Care Institute	Birmingham	Alabama
United States	Comprehensive Cancer Center	Boca Raton	Florida
United States	Peak Performance Wellness	Flagstaff	Arizona
United States	California Cancer Care Inc	Greenbrae	California
United States	Gynecologic Oncology Associates and Development LLC	Greenville	South Carolina
United States	Markey Cancer Center	Lexington	Kentucky
United States	UW Comprehensive Cancer Center	Madison	Wisconsin
United States	Osler Clinical Research/Osler Medical Inc	Melbourne	Florida
United States	University of Miami, Sylvester Cancer Research Center	Miami	Florida
United States	Clinical Trials and Research Associates	Montebello	California
United States	Beth Israel Cancer Center	New York	New York
United States	Comprehensive Cancer Centers of the Desert	Palm Springs	California
United States	Cancer Research Network Inc	Plantation	Florida
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Northwest Medical Specialists, PLLC	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Arizona Clinical Research Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Celgene Corporation

Country where clinical trial is conducted

United States,