Neurocognitive and Psychological Impact of Chemotherapy in Breast Cancer Patients: A Prospective Observational Study
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Chemotherapy-induced Peripheral Neuropathy. Базовые параметры: 18 лет — 70 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Despite growing awareness of neurocognitive and psychological complications of systemic chemotherapy administration in breast cancer, prospective observational studies evaluating such effects in Egyptian breast cancer patients-especially with pre- and post-treatment assessments-remain limited. Given the rising incidence of breast cancer in Egypt and the growing population of long-term survivors, it is essential to investigate the extent and nature of cognitive and psychological changes associated with treatment. The current study aims to fill this gap by prospectively evaluating neurological, cognitive, and psychological parameters in newly diagnosed breast cancer patients, using validated tools before and one year after treatment.
Подробное описание
Patient Recruitment This prospective observational study will include female breast cancer patients who will be recruited from the neuropsychiatry, Clinical Oncology, and general surgery departments, as well as from outpatient clinics at Sohag University Hospital.
Inclusion Criteria Female patients with newly diagnosed breast cancer will be included. All patients will be evaluated before the initiation of treatment and again one year after treatment completion.
Study Methodology
All enrolled patients will undergo the following assessments:
Complete History taking: thorough medical, neurological, and oncological history will be obtained, including comorbidities and current medications.
Neurological Examination: Each patient will receive a comprehensive clinical neurological examination at baseline and one year after treatment.
Neuroimaging: Brain MRI will be performed to detect any structural brain abnormalities or metastatic lesions.
Neurophysiological Assessment Nerve conduction studies (NCS) will be conducted to evaluate for peripheral neuropathy.
Cognitive Function Assessment
Cognitive testing will be carried out at baseline and at the one-year follow-up using the following tools:
A. Wisconsin Card Sorting Test (WCST) This test will assess executive functions such as cognitive flexibility and set shifting.
Higher perseverative error scores will indicate poorer performance (7). B. Trail Making Test (TMT), Parts A \& B Part A: Patients will connect sequential numbers to assess visual attention and processing speed.
Part B: Patients will alternate between numbers and letters (1-A-2-B…) to assess executive functioning.
Errors will be corrected by the examiner in real time (8). C. Montreal Cognitive Assessment (MoCA) This test will evaluate attention, memory, language, executive functions, visuospatial skills, and orientation.
Total score: 0-30, with higher scores indicating better function. (Nasreddine et al., 2005)
Первичные конечные точки
- chemotherapy-induced peripheral neuropathy [Срок оценки: 1 year, 2 years]
- psychological impact of chemotherapy adminstration [Срок оценки: 1 year, 2 years]
Критерии участия
Критерии включения
- Newly diagnosed breast cancer female patients.
- Chemotherapy is indicated for these patients either preoperative or postoperative.
Критерии исключения
- known history of neurological disease.
- presence of symptoms suggesting positive neurological disease.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Египет · 1 центр
- Sohag University — Sohag
Идентификаторы
NCT: NCT07184749 · Soh-Med-25-7-8PD · Sohag University