RECRUITING

A Study Utilizing Escitalopram in Glioma Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-03-06
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03728673

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically proven diagnosis of Grade IV glioma
  2. * Newly diagnosed disease to receive chemotherapy and/or radiation
  3. * Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 or equivalent
  4. * 19 years of age or older
  5. * Life expectancy greater than 6 months
  6. * Able to provide written informed consent for study participation
  7. * Negative urine pregnancy test at enrollment for females of childbearing potential
  8. * 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
  1. * Hemifield defects (obscures visual field necessary to participate in all tests)
  2. * Inability to undergo MRI
  3. * Severe renal impairment defined as Glomerular Filtration Rate (GFR) \<30 mL/minute
  4. * Screen positive for depression or anxiety
  5. * Already taking an anti-depressant (SSRI or NSRI)
  6. * Have problems tolerating past treatment with SSRI or NSRIs

Contacts and Locations

Study Contact

Michaela K Savine, RN
CONTACT
402-836-9488
misavine@unmc.edu

Principal Investigator

Nicole A Shonka, MD
PRINCIPAL_INVESTIGATOR
University of Nebraska

Study Locations (Sites)

University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States

Collaborators and Investigators

Sponsor: University of Nebraska

  • Nicole A Shonka, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-06
Study Completion Date2027-08

Study Record Updates

Study Start Date2019-03-06
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • serotonin selective reuptake inhibitor
  • cognition
  • escitalopram

Additional Relevant MeSH Terms

  • Glioma of Brain
  • Glioma