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Идёт набор NCT03728673

A Study Utilizing Escitalopram in Glioma Patients

Фаза II С лечением Glioma of Brain Glioma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Escitalopram Oral Capsules.
Кому может быть актуально
Состояния в реестре: Glioma of Brain, Glioma. Базовые параметры: от 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Nebraska Medical Center — Omaha

Идентификаторы

NCT: NCT03728673 · 0245-18-FB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗