Lithium Treatment to Prevent Cognitive Impairment After Brain Radiotherapy
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: Lithium, Placebo.
- Кому может быть актуально
- Состояния в реестре: Cognitive Impairment, Cognitive Decline, Radiotherapy Side Effect, Radiotherapy; Complications. Базовые параметры: от 5 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
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Randomized, placebo-controlled, double-blinded, parallel group clinical trial to investigate if 6 months of oral lithium tablets (S-lithium 0,5-1,0 mmol/l) will prevent cognitive decline after brain radiotherapy in pediatric brain tumor survivors. Primary outcome measure is Processing Speed Index (PSI) 2 years after start of study treatment.
Подробное описание
Late-appearing cognitive side effects after brain radiotherapy is a potential disabling condition in pediatric brain tumor survivors. It can have profound negative effects on education, career options and quality of life. There is no current interventional drug treatment to prevent this intellectual impairment after brain tumor treatment.
Primary objective:
To assess the efficacy of lithium treatment (up to 7 years) after brain radiotherapy (both whole brain and focal) for central nervous system malignancy in preventing late-appearing cognitive processing speed impairment in children aged 5 or older.
Secondary objectives:
* To assess the efficacy of lithium treatment through evaluation of other neuropsychological/quality of life test scores. * To assess the efficacy of lithium treatment through evaluation of radiological findings after lithium treatment using Magnetic Resonance Imaging (MRI) of the brain.
Exploratory objectives:
To explore the feasibility, safety and tolerability of lithium treatment in this patient group, using side effect forms/adverse events (AE) reporting and laboratory measures.
Вмешательства
- Препарат Lithium
Lithium sulphate, 42 mg (6 mmol lithium) - Препарат Placebo
White round tablet, 10 mm. Identical to experimental drug (lithium)
Первичные конечные точки
- Processing Speed Index (PSI) [Срок оценки: 2 years after start of study treatment]
Вторичные конечные точки (12)
- Fractional anisotropy (FA) index [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Other Wechsler Intelligence scale scores (except PSI): [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Grooved pegboard [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Beery/Buktenica visual motor integration (VMI) [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Conner´s Continous Performance Test (CPT) III [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Delis-Kaplan Executive Function System Trail Making Test (D-KEFS TMT) [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Delis-Kaplan Executive Function System Color-Word Interference Test (D-KEFS CWT), age 8 years and above. [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Nepsy II: Inhibition, Verbal Fluency, [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Pediatric QoL Inventory (PedsQL) [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- University of California Los Angeles (UCLA) 3-Item Loneliness Scale (ULS-3) [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
- Behavior Rating Inventory of Executive Function (BRIEF). [Срок оценки: Baseline (before treatment) - 5 years after start of study treatment]
Критерии участия
Критерии включения
- Age >5 years.
- Age <18 years at time of radiotherapy.
- Has received cranial/craniospinal radiation treatment of brain tumor within the last 7 years.
- Adequate contraceptive method to prevent pregnancy\* during the entire lithium treatment period and six months thereafter.
- Negative pregnancy test\* at screening, at start of study treatment, and monthly thereafter.
- Written informed consent from patient and/or caregiver.
Критерии исключения
- Allergy/hypersensitivity to lithium or any of the excipients
- Renal failure (Cystatin C derived Glomerular Filtration Rate < 60).
- Cardiac failure or heart disease, including Brugada syndrome (or family history thereof).
- Uncontrolled hypothyroidism.
- Pregnancy or breast feeding.
- Severe fluid or electrolyte imbalance.
- Karnofsky-Lansky score < 60.
- Other condition deemed incompatible with inclusion in this study (estimated 2 year survival prognosis less than 25 %, expected poor protocol compliance, inability to swallow tablets, language difficulties).
- Inclusion in other study protocol precluding inclusion in this study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Профилактика
Центры проведения
Швеция · 2 центра
- Karolinska Universitetssjukhuset — Solna
- HOPE — Stockholm
Идентификаторы
NCT: NCT06051240 · 2023-504071-24-00 · 2023-504071-24-00