Status:
COMPLETED
Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Cephalon
Conditions:
Cancer
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 effe...
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 occur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2006
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00178373
Start Date
May 1 2004
End Date
March 1 2006
Last Update
December 23 2015
Active Locations (1)
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1
University of Rochester, James P. Wilmot Cancer Center
Rochester, New York, United States, 14642