Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Cephalon
• Treatments: Armodafinil; Modafinil

Criteria

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