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

Sponsor

Celgene Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00047476

Collaborator

(none)

160

Enrollment

Locations

Duration (Months)

7.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fatigue Neoplasms	Drug: dexmethylphenidate(d-mph)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2002

Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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