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Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178373
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 23, 2015
Information provided by (Responsible Party):
Gary Morrow, University of Rochester

Brief Summary:

The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed.

The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.

Condition or disease Intervention/treatment Phase
Cancer Fatigue Chemotherapy Drug: Modafinil Drug: sugar pill Phase 2

Detailed Description:

Fatigue is a very common and troublesome side effect experienced in cancer patients before, during and after chemotherapy and radiation treatment. This protocol will increase knowledge about the occurrence and treatment of fatigue that develops during cancer treatments with the rationale that:

  1. better control of the fatigue reported by patients during and following cancer treatment is needed,
  2. there are few systematic data on the etiology of fatigue following cancer treatment, and
  3. there is evidence indicating that chemotherapy is associated with cognitive dysfunction.

Comparisons: In this randomized, placebo-controlled study of cancer patients following their chemotherapy or radiation therapy, we will assess the efficacy of modafinil for relieving cancer-related fatigue by actigraphy and for preventing or improving cognitive dysfunction by computer-generated tasks that have previously been utilized to examine drug-induced changes in performance (CDR Cognitive Assessment). Additional outcome measures will include the Fatigue Symptom Checklist, POMS, Fatigue Severity Scale, sleepiness measured by the Epworth Sleepiness Scale, cytokine blood levels, depression measured by the CES-D, and psychological adjustment to cancer measured by the Mini-MAC.

The primary objective is to:

  • compare changes in patient reported fatigue following completion of chemotherapy and/or radiation treatment for cancer in patients who receive open-label modafinil (PROVIGIL®) for 4 weeks

Secondary objectives are to:

  • assess the persistence of any effect found with a randomized trial of responders to modafinil or placebo for 4 weeks (responders are those who report at least a 1 point decrease in fatigue as measured by the Brief Fatigue Inventory)
  • assess the degree to which modafinil can prevent or reduce cognitive dysfunction following treatment for cancer
  • investigate potential relationships among depression, fatigue, cytokines, and cognitive dysfunction

Anticipated results could provide potentially important new information with regard to clinical, theoretical, and methodologic applications; that is, improved pharmacologic and perhaps behavioral control of the debilitating fatigue commonly experienced by patients undergoing treatment for cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer
Study Start Date : May 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Modafinil

Arm Intervention/treatment
Experimental: Modafinil
Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning.
Drug: Modafinil
Placebo Comparator: placebo
Inactive sugar pill, 2 are taken once a day in the morning
Drug: sugar pill

Primary Outcome Measures :
  1. degree to which modafinil can reduce patient fatigue following treatment for cancer [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. cytokine blood levels
  2. depression measured by the Center for Epidemiologic Studies-Depression scale (CES-D)
  3. cognitive function measured by the Cognitive Drug Research (CDR) Cognitive Assessment
  4. psychological adjustment to cancer measured by the Mini-Mental Adjustment to Cancer scale (Mini-MAC)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer
  • Patient is 18 years of age or older
  • Patient is able to swallow medication
  • Patient has a Brief Fatigue Inventory (BFI) question #3 "fatigue worst" score of 2 or greater

Exclusion Criteria:

  • Patient has ever taken modafinil (PROVIGIL)
  • Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate [Ritalin], pemoline [Cylert]), or a monoamine oxidase inhibitor (MAOIs)
  • Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome
  • Patient presently taking on a regular basis:

    • an anticoagulant (Coumadin [warfarin], heparin); note that low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable
    • alpha-interferon or interleukin-2,
    • a corticosteroid (dexamethasone, prednisone, prednisolone)
  • Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
  • Patient is currently pregnant or nursing (if currently using a steroidal contraceptive for fertility control, participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study
  • Patient has uncontrolled anemia; receiving treatment for anemia and currently stable is acceptable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178373

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United States, New York
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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Principal Investigator: Gary R. Morrow, Ph.D., M.S. University of Rochester, James P. Wilmot Cancer Center, Radiation Oncology Department, Behavioral Medicine Unit, Box 704, 601 Elmwood Avenue, Rochester, NY 14642
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Responsible Party: Gary Morrow, Professor, University of Rochester Identifier: NCT00178373    
Other Study ID Numbers: U2702
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015
Keywords provided by Gary Morrow, University of Rochester:
cancer-related fatigue
Additional relevant MeSH terms:
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Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action