Clinical Biomarker of Paclitaxel-induced Peripheral Neuropathy
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: No intervention.
- Кому может быть актуально
- Состояния в реестре: Chemotherapy-induced Peripheral Neuropathy. Базовые параметры: от 18 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
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Investigation of which patients treated with paclitaxel have an increased risk of developing peripheral neuropathy.
Подробное описание
The primary aim of this study is to validate the protein neurofilament light chain (NFL) as a biomarker of the side effect paclitaxel-induced peripheral neuropathy (PIPN) and its utility in predicting this side effect in patients with breast cancer. The investigators want to include 188 patients at four different trial sites. The patients must follow their normal treatment cycles while getting blood drawn during their treatment period however maximal 4 cycles.
Blood samples are dawn before treatment initiation and once before each new cycle start in order to measure neurofilament light chain (NFL) before and during treatment. The investigators also want to take a skin biopsy before treatment start and after either cycle 3 or 4.
The primary endpoint of the study is if serum NFL\>100 pg/ml after first cycle of paclitaxel can predict early termination of paclitaxel due to peripheral neuropathy.
Вмешательства
- Другое No intervention
No intervention
Первичные конечные точки
- NFL level correlation [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
Вторичные конечные точки (9)
- Paclitaxel exposure [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Genes and PIPN [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Genes and NFL [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Genes and Paclitaxel [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Drug-drug interactions [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Skin biopsies [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- IENFD [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- PHS [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
- Nerve fiber dysfunction [Срок оценки: Before treatment start and during four cycles (one cycle equals 3 weeks)]
Критерии участия
Критерии включения
- Age > 18 years
- Willing to give informed consent
- Scheduled to receive neo-adjuvant or adjuvant paclitaxel treatment
- Able to speak and understand Danish
- Diagnosed with breast cancer
- Paclitaxel naïve patients
Критерии исключения
- Neurodegenerative diseases (e.g., neuropathy from another cause, previous apoplexy, disc herniation
- Type 1 or 2 diabetes
- Pregnant
- Breastfeeding
- Relapse of cancer diagnosis
- Diagnosed with human immunodeficiency virus (HIV)
- Participation in other clinical trials where the dose of paclitaxel is changed, or the aim is to prevent neuropathic pain or decrease NFL level (except if the intervention is to use cooling gloves).
- Previous treatment with neurotoxic chemotherapy
- Chronic pain from another cause
- Metastatic cancer
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Дания · 3 центра
- Odense University Hospital — Odense
- University Hospital of Southern Denmark, Sønderborg — Sønderborg
- University Hospital of Southern Denmark, Vejle — Vejle
Идентификаторы
NCT: NCT06430814 · AKF-403