A Study Utilizing Escitalopram in Glioma Patients

University of Nebraska

Status and phase

Enrolling

Phase 2

Conditions

Glioma

Glioma of Brain

Treatments

Drug: Escitalopram Oral Capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT03728673

0245-18-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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