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FatiguePhase 3NCT00042848

Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

A Phase 3 study testing modafinil in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by Gary Morrow at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
modafinil
How many people
837 participants
Where
35 sitesUnited States
Study dates
Aug 2002to Oct 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Medical Center of Aurora - South Campus

    Aurora, Colorado, 80012-0000

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612-7323

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • St. Joseph Hospital

    Denver, Colorado, 80218-1191

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers - Denver Rose

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program

    Denver, Colorado, 80224

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Swedish Medical Center

    Englewood, Colorado, 80112

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers - Longmont

    Longmont, Colorado, 80501

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36606

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • St. Mary-Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Rocky Mountain Cancer Centers - Thornton

    Thornton, Colorado, 80229

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
modafinil
Keywords
fatigue, unspecified adult solid tumor, protocol specific
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • modafinilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

  1. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionApr 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Masking
Double blind
Enrolment
837 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00042848
Sponsor's protocol ID
CDR0000069477
Other IDs
U10CA037420, URCC-U2901
Status last verified
Oct 2015
First submitted
5 Aug 2002
Last updated
15 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Jean-Pierre P, Morrow GR, Roscoe JA, Heckler C, Mohile S, Janelsins M, Peppone L, Hemstad A, Esparaz BT, Hopkins JO. A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. Cancer. 2010 Jul 15;116(14):3513-20. doi: 10.1002/cncr.25083.

    PubMed 20564068

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing modafinil in people with Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, run by Gary Morrow at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy to reduce fatigue during chemotherapy as assessed by the Brief Fatigue Inventory at course 4. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00042848, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.

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