Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
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: Nicotinamide Riboside, Placebo.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Metastatic Breast Cancer, Cancer Therapy-Related Cardiac Dysfunction, Cardiotoxicity. 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
- Норвегия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Nicotinamide Riboside on Myocardial and Skeletal Muscle Injury and Function in Patients With Metastatic Breast Cancer Receiving Anthracyclines
Обзор
Breast cancer is the most common form of cancer in women. Modern breast cancer treatments have led to increased survival, but at the same time, increased risk for cardiotoxicity and development of heart failure. In this study, the investigators want to evaluate whether nicotinamide riboside can prevent cancer-related cardiac dysfunction in metastatic breast cancer patients scheduled for anthracycline therapy. Further, the investigators will evaluate change in signs of skeletal muscle injury and functional capacity.
Подробное описание
The trial is prospective, randomised, double-blind and placebo-controlled. The primary objective is change in left ventricular ejection fraction (LVEF), determined by cardiac MRI (CMR). Secondary objectives are change in circulating high-sensitivity cardiac troponin I and T (hs-TnI and hs-TnT), Creatine Kinase (CK) and myoglobin, and various measurements of change in left ventricular systolic function determined by CMR and echocardiography. Additional assessments are evaluation of the patient's functional capacity and the patients will be asked to fill out questionnaires to assess quality of life.
60 patients will be randomised in a 1:1 ratio. The duration of blinded therapy will depend on the duration of anthracycline therapy. All patients will be examined at baseline and 3 months, and if the patient is scheduled for extended anthracycline therapy, an additional examination will be performed at 6 months.
Вмешательства
- Пищевая добавка Nicotinamide Riboside
Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy - Пищевая добавка Placebo
Matching placebo b.i.d as long as the patient is receiving anthracycline therapy
Первичные конечные точки
- Whether the administration of nicotinamide riboside can prevent the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR), compared to placebo. [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
Вторичные конечные точки (8)
- Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
- Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
- Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
- Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
- To assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin T (hs-cTnT) [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
- To assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin I (hs-cTnI) [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
- To assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
- To assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity [Срок оценки: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy]
Критерии участия
Критерии включения
- Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy
- Eastern Cooperative Oncology Group performance status 0-2
Критерии исключения
- Age <18 years
- Acute myocardial infarction within the last three months
- Participation in another pharmaceutical clinical trial of an investigational medicinal product (IMP) less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longer
- Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers
- Life expectancy < 6 months
- Known allergy to any of the components in the Nicotinamide Riboside (Niagen®) tablet
- Contraindications or inability to undergo CMR examination
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
Норвегия · 1 центр
- Akershus University Hospital — Lørenskog
Идентификаторы
NCT: NCT05732051 · 2021/156064(REK)