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

June 23, 2005 updated by: Celgene Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Cooper Green Hospital, Jefferson Clinic
      • Birmingham, Alabama, United States, 35294-0023
        • University of Alabama Palliative Care Institute
    • Arizona
      • Flagstaff, Arizona, United States, 86004
        • Peak Performance Wellness
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Greenbrae, California, United States, 94904-2007
        • California Cancer Care Inc
      • Montebello, California, United States, 90640
        • Clinical Trials and Research Associates
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Centers of the Desert
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Comprehensive Cancer Center
      • Melbourne, Florida, United States, 32901
        • Osler Clinical Research/Osler Medical Inc
      • Miami, Florida, United States, 33139
        • University of Miami, Sylvester Cancer Research Center
      • Plantation, Florida, United States, 33324
        • Cancer Research Network Inc
      • Tampa, Florida, United States, 33162
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Markey Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Cancer Center
    • South Carolina
      • Greenville, South Carolina, United States, 29604
        • Gynecologic Oncology Associates and Development LLC
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialists, PLLC
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • UW Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

October 8, 2002

First Submitted That Met QC Criteria

October 8, 2002

First Posted (Estimate)

October 9, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • d-MPH-COG-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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