Clinical trial · Interventional
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
- 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)
RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known. PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| modafinil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- drug dosage 1
- description
- \- Arm I: Patients receive oral high-dose modafinil twice daily.
- interventionNames
- Drug: modafinil
- type
- EXPERIMENTAL
- label
- drug dosage 2
- description
- \- Arm II: Patients receive oral low-dose modafinil twice daily.
- interventionNames
- Drug: modafinil
Primary outcomes (1)
- measure
- Neurocognitive functioning
- timeFrame
- at baseline and weeks 1, 3, 4, 8, and 10
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program * Nonmalignant cerebral tumors also allowed * Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy * Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale * Age 21 to 65 * Able to speak English * Capable of completing self-rating scales and one-on-one psychometric tests * Negative pregnancy test * Fertile patients must use effective contraception * Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed * Concurrent glucocorticoids (e.g., dexamethasone) allowed * Concurrent tamoxifen allowed * At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate) * Concurrent anticonvulsants allowed * Concurrent isotretinoin allowed Exclusion Criteria: * Have significant hepatic disease, defined as SGOT greater than or equal to 2.5 times the upper limit of normal. * Have significant renal disease, defined as creatinine greater than or equal to 1.5mg/dl. * severe cognitive impairment * other terminal illness * emergency patient * institutional resident * prisoner or parolee * UCLA students or staff * pregnant or nursing * concurrent irinotecan * concurrent participation in UCLA experimental chemotherapy trials * prior modafinil * concurrent experimental anticancer medication * concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors
References
Publications (0)
Data not yet available