Clinical trial NCT00047476: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fatigue
Neoplasms
Keywords: neurobehavioral function
chemobrain
chemo brain
fatigue
memory loss
exhausted
trouble concentrating
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2002-10-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

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