Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

October 13, 2015 updated by: Gary Morrow

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

RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known.

PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

837

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36606
        • MBCCOP - Gulf Coast
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Western Regional, Arizona
    • California
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
    • Colorado
      • Aurora, Colorado, United States, 80012-0000
        • Medical Center of Aurora - South Campus
      • Boulder, Colorado, United States, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, United States, 80218-1191
        • St. Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers - Denver Rose
      • Denver, Colorado, United States, 80224
        • CCOP - Colorado Cancer Research Program
      • Englewood, Colorado, United States, 80112
        • Swedish Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers - Longmont
      • Pueblo, Colorado, United States, 81004
        • St. Mary-Corwin Regional Medical Center
      • Thornton, Colorado, United States, 80229
        • Rocky Mountain Cancer Centers - Thornton
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612-7323
        • MBCCOP - University of Illinois at Chicago
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Evanston, Illinois, United States, 60201
        • CCOP - Evanston
    • Kansas
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
    • Michigan
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
    • Minnesota
      • St. Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New York
      • East Syracuse, New York, United States, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • Manhasset, New York, United States, 11030
        • CCOP - North Shore University Hospital
    • North Carolina
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Columbus, Ohio, United States, 43215
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
    • Oregon
      • Portland, Oregon, United States, 97225
        • CCOP - Columbia River Oncology Program
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
    • Washington
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Clinic Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Relationship between depression and fatigue during chemotherapy as assessed by Fatigue Symptom Checklist, Profile of Mood States, Fatigue Severity Scale, Epworth Sleepiness Scale, Center for Epidemiologic Studies-Depression, and Mini-Mac at course 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gary Morrow

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Gary R. Morrow, PhD, MS, James P. Wilmot Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

August 5, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069477
  • U10CA037420 (U.S. NIH Grant/Contract)
  • URCC-U2901 (Other Identifier: University of Rochester)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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