Clinical trial · Interventional
Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapy | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modafinil | Drug | — | UNRESOLVED |
| sugar pill | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Modafinil
- description
- Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning.
- interventionNames
- Drug: Modafinil
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Inactive sugar pill, 2 are taken once a day in the morning
- interventionNames
- Drug: sugar pill
Primary outcomes (1)
- measure
- degree to which modafinil can reduce patient fatigue following treatment for cancer
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available