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Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b


Phase 3
18 Years
N/A
Not Enrolling
Both
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Double-Blind Randomized Trial of Methylphenidate for Alleviation of Fatigue and Lethargy Associated With Interferon Alpha 2b


OBJECTIVES: I. Determine whether methylphenidate decreases fatigue and lethargy in cancer
patients receiving interferon alfa. II. Determine whether the use of methylphenidate in this
patient population decreases the number of dose reductions of interferon alfa due to
toxicities other than myelosuppression or elevated liver function tests. III. Assess whether
efficacy or toxicity of methylphenidate in this patient population is concentration
dependent. IV. Compare the fatigue subscale and the proposed Brief Fatigue Inventory.

OUTLINE: This is a randomized, double-blind, placebo-controlled, two arm study. Patients are
stratified according to initial fatigue level (high vs moderate), and treatment with tumor
vaccine (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients
receive oral methylphenidate twice daily. Arm II: Patients receive oral placebo twice daily.
Treatment is continued for 21 consecutive days with dose escalations as tolerated and as
needed by patient judgement, followed by an additional week to evaluate the effect of drug
withdrawal. Patients are contacted by telephone at least twice weekly during the 21 day
treatment and 7 day washout phase to assess adverse or rebound effects. Before the study
begins and at weekly clinic visits for the 4 week study period, patients complete a series
of questionnaires to measure mood, levels of fatigue and lethargy, and sense of well being.
Patients also keep a short daily diary of study medication doses and degree of tiredness.
Patients are followed every 3 months for 2 years, then every 6 months for the next 3 years,
and then annually thereafter.

PROJECTED ACCRUAL: A total of 200 patients will be accrued into this study within 39 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: On interferon alfa-2b treatment for at least 8 weeks Dose must be
stable for 2 weeks prior to and during study Fatigue level at least 4 on the Symptom and
Fatigue Self Evaluation Form (0 none, 10 worst possible)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: More than 4 weeks Hematopoietic: Hematocrit at least 30% Hepatic: Not
specified Renal: Creatinine no greater than 2.0 mg/dL Other: No history of any of the
following: Chronic use of anticonvulsants Seizure disorder Motor tics Glaucoma Family
history or diagnosis of Tourette's disorder No allergic reaction or hypersensitivity to
methylphenidate Cognitively able to participate Not incarcerated Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics No monoamine oxidase inhibitors
within 2 months

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Paul R. Hutson, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000066161

NCT ID:

NCT00003266

Start Date:

June 1999

Completion Date:

Related Keywords:

  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • fatigue
  • Fatigue

Name

Location

Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford University Medical CenterStanford, California  94305-5408
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
University of Rochester Cancer CenterRochester, New York  14642
Ireland Cancer CenterCleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Colorado Cancer Research Program, Inc.Denver, Colorado  80209-5031
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
CCOP - OklahomaTulsa, Oklahoma  74136
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Veterans Affairs Medical Center - GainsvilleGainesville, Florida  32608-1197