Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer
NCT ID: NCT00178373
Last Updated: 2015-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2004-05-31
2006-03-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Modafinil
Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning.
Modafinil
placebo
Inactive sugar pill, 2 are taken once a day in the morning
sugar pill
Interventions
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Modafinil
sugar pill
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
University of Rochester
OTHER
Responsible Party
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Gary Morrow
Professor
Principal Investigators
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Gary R. Morrow, Ph.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester, James P. Wilmot Cancer Center, Radiation Oncology Department, Behavioral Medicine Unit, Box 704, 601 Elmwood Avenue, Rochester, NY 14642
Locations
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University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, United States
Countries
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Other Identifiers
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U2702
Identifier Type: -
Identifier Source: org_study_id