Clinical trial · Observational
Bioenergetic Profiling and Cognition in GBM Patients
Blood-based Bioenergetic Profiling and Cognition in Glioblastoma Patients
NCT03939858CI-TRIAL-00071162terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding and laboratory access issues, study is closed
Summary
Brief summary (as posted)
This trial studies the use of blood-based bioenergetic profiling and cognitive testing in assessing patients with glioblastoma undergoing chemoradiation therapy. The purpose of this pilot research study is to find out if it is possible to see changes in participants' mitochondria, parts of a cell that produce energy, that might be associated with changes in participants' brain function after chemoradiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioenergetic Profiling | Diagnostic Test | — | UNRESOLVED |
| Blood Collection | Diagnostic Test | — | UNRESOLVED |
| Cognitive Assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cognitive Function Analysis
- description
- Cognitive function will be evaluated using a customized cognitive battery designed for brain tumor patients. Tests have been selected to represent a range of cognitive functions affected by cancer and radiotherapy including basic attention, recent memory, executive functions (spanning verbal fluency, cognitive set-shifting, and abstract reasoning), and visual perceptual/spatial skills.
- interventionNames
- Procedure: Cognitive Assessment
- Diagnostic Test: Blood Collection
- Diagnostic Test: Bioenergetic Profiling
Primary outcomes (1)
- measure
- Number of Patients Completing Bioenergetics Profiling
- timeFrame
- 3 months
- description
- The primary outcome will be the proportion of patients who are able to have bioenergetic profiling completed at all three time points (baseline, one month after radiotherapy, three months after radiotherapy). The proportion and its 95% confidence interval will be calculated.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: • Glioma patients greater than 18 years old receiving chemoradiation with a Karnofsky Performance Status greater than or equal to 50. Exclusion Criteria: * Prior diagnosis (by a physician or neuropsychologist) of any type of dementia (AD, frontotemporal dementia, vascular dementia, Lewy-body dementia, Parkinson's dementia), normal pressure hydrocephalus, Creutzfeldt Jacob disease, posterior cortical atrophy, Huntington's disease, or Korsakoff syndrome will be excluded. Patients who were diagnosed with Mild Cognitive (MCI) Impairment greater than or equal to 1 year prior to diagnosis with their high grade glioma will also be excluded. Patients reported by family members as having memory problems or with subjective memory complaints are still eligible. * Patients taking medications known to have a mitotoxic effect (see attached appendix). Patients who take any of the as needed medications on the list more than 4 times per week will be excluded. There are medications that are considered mitotoxic that are not included on this list because of the essential nature of the medications to this population (steroids, anti-seizure medications, diabetic medications etc.) or high frequency of use in this population (statins, beta blockers). * Patients on medications with the potential to enhance cognition including donepezil, memantine, armodafinil or methylphenidate. * Patients who are not fluent in English will be excluded. * Patients with aphasia or other neurologic deficit which would prevent participating in cognitive testing will be excluded. * Patients who are unable to fast for 8 hours will be excluded since enrolled patients will only be able to drink water for the 8 hours before blood draws. * Patients who drink more than 14 alcoholic drinks per week. * Patients who are active smokers.
References
Publications (0)
Data not yet available
No reference posted for this study.