Back to resultsD-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
Primary Purpose
Fatigue, Neoplasms
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexmethylphenidate(d-mph)
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue focused on measuring neurobehavioral function, chemobrain, chemo brain, fatigue, memory loss, exhausted, trouble concentrating
Eligibility 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.
Sites / Locations
- Cooper Green Hospital, Jefferson Clinic
- University of Alabama Palliative Care Institute
- Peak Performance Wellness
- Arizona Clinical Research Center
- Alta Bates Comprehensive Cancer Center
- California Cancer Care Inc
- Clinical Trials and Research Associates
- Comprehensive Cancer Centers of the Desert
- Comprehensive Cancer Center
- Osler Clinical Research/Osler Medical Inc
- University of Miami, Sylvester Cancer Research Center
- Cancer Research Network Inc
- H. Lee Moffitt Cancer Center and Research Institute
- Piedmont Hospital
- Markey Cancer Center
- Sinai Hospital of Baltimore
- Beth Israel Cancer Center
- Gynecologic Oncology Associates and Development LLC
- Seattle Cancer Care Alliance
- Northwest Medical Specialists, PLLC
- UW Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00047476
Brief Title
D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
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 Type
Interventional
2. Study Status
Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Celgene Corporation
4. Oversight
5. Study Description
Brief Summary
To evaluate the efficacy of dexmethylphenidate (d-MPH) in the treatment of chemotherapy-related fatigue in adult cancer subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Neoplasms
Keywords
neurobehavioral function, chemobrain, chemo brain, fatigue, memory loss, exhausted, trouble concentrating
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
dexmethylphenidate(d-mph)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Cooper Green Hospital, Jefferson Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama Palliative Care Institute
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0023
Country
United States
Facility Name
Peak Performance Wellness
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86004
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
California Cancer Care Inc
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
Clinical Trials and Research Associates
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Comprehensive Cancer Centers of the Desert
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Comprehensive Cancer Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Osler Clinical Research/Osler Medical Inc
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
University of Miami, Sylvester Cancer Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
Cancer Research Network Inc
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Beth Israel Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Gynecologic Oncology Associates and Development LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29604
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Northwest Medical Specialists, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
UW Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
12. IPD Sharing Statement
Learn more about this trial
D-MPH in the Treatment of Fatigue and Neurobehavioral Function Related to Chemotherapy in Adult Cancer Patients
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