Clinical trial NCT03939858: Bioenergetic Profiling and Cognition in GBM Patients
Official title: Blood-based Bioenergetic Profiling and Cognition in Glioblastoma Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioblastoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glioma patients receiving chemoradiation

Brief summary: 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.

Detailed description: Primary Objective:

• To determine the feasibility of performing bioenergetic profiling in glioblastoma patients receiving chemoradiation by ascertaining the proportion of patients who have enough white blood cells in a 16 mL blood to successfully perform the profiling assays.

Secondary Objectives:

• To determine if either pre-radiotherapy bioenergetic profile or the change in bioenergetic profile from pre-radiotherapy to post-radiotherapy are predictive of subacute cognitive decline after radiation.

OUTLINE: Patients undergo neurocognitive testing over 1 hour using a customized battery of tests designed for brain tumor patients at Wake Forest Baptist Comprehensive Cancer Center. Patients also undergo blood collection at baseline and at 1 and 3 months post radiotherapy.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients Completing Bioenergetics Profiling
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of Participants with Decline in Cognitive Function
timeFrame: Three months after completion of radiotherapy
measure: Bioenergetics Profiling Testing - Seahorse XFe24 Analyzer
timeFrame: Three months after completion of radiotherapy
measure: Bioenergetics Profile Testing - Oroboros O2K
timeFrame: Three months after completion of radiotherapy
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christina Cramer, MD
role: PRINCIPAL_INVESTIGATOR
References: