Clinical trial · Interventional
Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
A Phase III, Double-Blind, Prospective Randomized Clinical Trial of the Effect of D-threo-methylphenidate HCl (d-MPH) on Quality of Life in Brain Tumor Patients Receiving Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual; loss of funding
Summary
Brief summary (as posted)
RATIONALE: Methylphenidate may decrease side effects of radiation therapy. It is not yet known if methylphenidate is effective in improving quality of life in patients with primary or metastatic brain tumors. PURPOSE: Randomized phase III trial to determine the effectiveness of methylphenidate in improving quality of life in patients who have brain tumors and are undergoing radiation therapy.
Conditions
Conditions (5)
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 | — |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methylphenidate hydrochloride | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic brain tumor OR * Histologically confirmed primary brain tumor * Glioblastoma multiforme * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Low-grade glioma * Meningioma * Ependymoma * Planned external beam cranial radiotherapy (partial or whole brain) with a total dose of at least 25 Gy in at least 10 fractions of 180-300 cGy each PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * WBC ≥ 1,500/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 75,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No hypertension or other cardiovascular disease requiring antihypertensives and/or other cardiovascular medications Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious medical or psychiatric illness that would preclude study participation * No hypersensitivity to study drug * No history of steroid psychosis * No family history of or active Tourette's Syndrome * No prior or active glaucoma PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior or concurrent chemotherapy allowed Endocrine therapy: * Concurrent steroids allowed Radiotherapy: * See Disease Characteristics * Prior radiotherapy allowed except to brain (including stereotactic radiosurgery) * No concurrent craniospinal axis radiotherapy Surgery: * Not specified Other: * No prior or concurrent medications for attention deficit disorder, anxiety disorder, schizophrenia, or substance abuse * No concurrent anti-depressants
References
Publications (0)
Data not yet available