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Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy


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

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Trial Information

Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of The Effect Of Modafinil On Fatigue In Cancer Patients Receiving Chemotherapy


OBJECTIVES:

- Assess the degree to which modafinil can reduce fatigue in cancer patients receiving
chemotherapy.

- Assess the relationship between depression and fatigue in patients treated with this
drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are randomized to 1 of 2 treatment arms.

- Arm I: Beginning on day 5 of the second course of chemotherapy, patients receive oral
modafinil once daily.

- Arm II: Beginning on day 5 of the second course of chemotherapy, patients receive oral
placebo once daily.

Treatment in both arms continues until day 7 of course 4 of chemotherapy in the absence of
disease progression or unacceptable toxicity.

Fatigue and quality of life are assessed on day 7 of courses 2-4 of chemotherapy.

PROJECTED ACCRUAL: A total of 837 patients will be accrued for this study within
approximately 2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of cancer

- Concurrently receiving or has previously received chemotherapy and is scheduled for
at least 3 additional courses of chemotherapy

- Each course of chemotherapy must be at least 2 weeks in duration

- No concurrent radiotherapy or interferon therapy

- Brief Fatigue Inventory question #3 "fatigue worst" score of 2 or greater 1 week
after first chemotherapy course

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- At least 6 months

Hematopoietic

- Not specified

Hepatic

- No uncontrolled anemia

Renal

- Not specified

Cardiovascular

- No history of clinically significant cardiac disease, including any of the following:

- Unstable angina

- Left ventricular hypertrophy

- Ischemic echocardiogram changes

- Chest pain

- Arrhythmia

- Other clinically significant manifestations of mitral valve prolapse in
association with use of central nervous system stimulants (e.g., caffeine,
amphetamines, or methylphenidate)

- No uncontrolled hypertension

Gastrointestinal

- Able to swallow medication

- No narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal
tract

Other

- No severe headaches

- No glaucoma

- No seizure disorder

- No narcolepsy

- No psychotic disorder

- No Tourette's syndrome

- No alcohol or drug abuse

- Not pregnant or nursing

- Fertile patients must use effective barrier contraception during and for at least 1
full menstrual cycle after study completion

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- No concurrent chronic corticosteroids

Radiotherapy

- See Disease Characteristics

Surgery

- Not specified

Other

- No prior modafinil

- At least 30 days since prior regular use of psychostimulants (e.g., amphetamines,
methylphenidate, or pemoline) or monoamine oxidase inhibitors (MAOIs)

- No concurrent alcohol

- Concurrent acetaminophen with codeine or hydrocodone bitartrate allowed

- Concurrent phenytoin allowed

- Concurrent warfarin for anticoagulation and low-dose warfarin (1 mg by mouth daily)
for maintenance of venous access devices allowed

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4

Principal Investigator

Gary R. Morrow, PhD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069477

NCT ID:

NCT00042848

Start Date:

August 2002

Completion Date:

October 2007

Related Keywords:

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

Name

Location

MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
CCOP - Colorado Cancer Research ProgramDenver, Colorado  80224-2522
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
MBCCOP - Gulf CoastMobile, Alabama  36688
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Medical Center of Aurora - South CampusAurora, Colorado  80012-0000
Rocky Mountain Cancer Centers - Denver RoseDenver, Colorado  80220
Rocky Mountain Cancer Centers - ThorntonThornton, Colorado  80229
Rocky Mountain Cancer Centers - LongmontLongmont, Colorado  80501