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Recruiting NCT03728673

A Study Utilizing Escitalopram in Glioma Patients

Phase II Interventional Glioma of Brain Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Escitalopram Oral Capsules.
Who it may be relevant to
Registry conditions: Glioma of Brain, Glioma. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients

Overview

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.

Detailed description

As many as 85% of patients with glioma, a cancer of glial cells, 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. Commonly, impairments in visuospatial skills and executive function are seen. There is evidence that serotonin selective reuptake inhibitors (SSRIs) such as escitalopram improve modulation and function of resting state networks, contribute to neuroplastic changes in brain regions subserving these abilities, and provide general functional support to neuronal cells. In addition to either improving cognition or preventing cognitive decline, treatment with an SSRI may also improve outcomes critical to overall survival in this vulnerable population, including functional independence, psychosocial stability, and quality of life.

This study will characterize the degree of change in cognition/brain function in participants with grade IV glioma planning to undergo concurrent chemoradiation therapy followed by temozolomide and 17 weeks of treatment with an SSRI, escitalopram, and determine the degree of change in psychosocial function as assessed via ratings in mood and quality of life. The study hypothesis is that following treatment with escitalopram participants will experience improved cognitive and mood function over time.

Interventions

  • Drug Escitalopram Oral Capsules
    Active capsules will contain 10 mg escitalopram oxalate.

Primary outcome measures

  • Change in Cognition [Time frame: Baseline, 12-weeks and 17-weeks]
  • Characterize the degree of change in cognition and brain function [Time frame: Baseline, 12-weeks and 17-weeks]
  • Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Depression [Time frame: Baseline, 12-weeks and 17-weeks]
  • Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Anxiety [Time frame: Baseline, 12-weeks and 17-weeks]
  • Change in Psycho-social Functions - PROMIS Neuro-QoL Item Bank v1.0 - Fatigue [Time frame: Baseline, 12-weeks and 17-weeks]

Eligibility criteria

Inclusion criteria

  • 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
  • Life expectancy greater than 6 months
  • Able to provide written informed consent for study participation
  • Negative urine pregnancy test at enrollment for females of childbearing potential
  • Female participants must be either post-menopausal (free from menses for 2 or more years), surgically sterilized, or willing to use two adequate barrier forms of contraception

Exclusion criteria

  • 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
  • Already taking an anti-depressant (SSRI or NSRI)
  • Have problems tolerating past treatment with SSRI or NSRIs

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Nebraska Medical Center — Omaha

Identifiers

NCT: NCT03728673 · 0245-18-FB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗