A Study Utilizing Escitalopram in Glioma Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska
About this trial
Glioma is a cancer of glial cells, a class of tissue supporting neuronal function in the brain. As many as 85% of glioma patients experience cognitive impairment. This is not only from direct tumor involvement, but also from therapy such as cranial radiation and chemotherapy, which degrades neuronal function. There is evidence that serotonin selective reuptake inhibitors (SSRIs), such as escitalopram, improve cognition or prevent cognitive decline and may also improve outcomes critical to overall survival including functional independence, psychosocial stability, and quality of life. This pilot study will evaluate the effectiveness of the selective serotonin reuptake inhibitor (SSRI) escitalopram for treating cognitive impairment in newly diagnosed grade IV glioma over a 17 week treatment period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically proven diagnosis of Grade IV glioma
Newly diagnosed disease to receive chemotherapy and/or radiation
Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 or equivalent
19 years of age or older
Disqualifiers
Hemifield defects (obscures visual field necessary to participate in all tests)
Inability to undergo MRI
Severe renal impairment defined as Glomerular Filtration Rate (GFR) <30 mL/minute
Screen positive for depression or anxiety
Trial design
Design model
Single group
Treatments tested in this trial
Escitalopram Oral Capsules
DrugActive capsules will contain 10 mg escitalopram oxalate.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: EscitalopramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Cognition
Changes in cognition will be measured using the NIH Toolbox neurocognitive assessments. The NIH Toolbox has excellent test / re-test reliability across composite domain scores r = .86 - .9263. It has also shown strong convergent (r = .78 - .9) and discriminant (r = .19 - .39) validities. It has been validated on groups of patients with Spinal Cord Injuries, Traumatic Brain Injury and Stroke. More recently a small group of patients diagnosed with diffuse glioma completed the NIH Toolkit Cognitive and Emotional batteries pre- and post-surgery. Results suggested good tolerance on the part of the patients and benefits of having a standardized battery that can be employed across sites. Paired t-test will be used to determine if the changes from baseline to the 17 week visit are significant. If assumptions for the paired t-test are not met, the non-parametric Wilcoxon sign rank test will be used instead.
Time frame
Baseline, 12-weeks and 17-weeks2
Characterize the degree of change in cognition and brain function
Changes in cognition and brain function will be measured via Patient-Reported Outcome Measurement Information System (PROMIS) Neuro-QoL Item Bank v2.0 - Cognitive Function assessment completed at baseline, 12 weeks, and 17 weeks. A higher score on this measure indicate higher cognitive function. The change from baseline will be compared with the Wilcoxon sign rank test.
Time frame
Baseline, 12-weeks and 17-weeks3
Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Depression
The degree of change in psychosocial functions will be assessed via patient-reported ratings in mood and quality of life. The following assessments will be completed: PROMIS Neuro-QoL Item Bank v1.0 - Depression; PROMIS Neuro-QoL Item Bank v1.0 - Anxiety; PROMIS Neuro-QoL Item Bank v1.0 - Fatigue. Higher scores on these assessments indicate higher levels of the concept being assessed. The changes from baseline will be compared with the Wilcoxon sign rank test.
Time frame
Baseline, 12-weeks and 17-weeks4
Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Anxiety
The degree of change in psychosocial functions will be assessed via patient-reported ratings in mood and quality of life. The following assessments will be completed: PROMIS Neuro-QoL Item Bank v1.0 - Depression; PROMIS Neuro-QoL Item Bank v1.0 - Anxiety; PROMIS Neuro-QoL Item Bank v1.0 - Fatigue. Higher scores on these assessments indicate higher levels of the concept being assessed. The changes from baseline will be compared with the Wilcoxon sign rank test.
Time frame
Baseline, 12-weeks and 17-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov