Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer
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 Neoplasms, Cardiovascular Diseases. Базовые параметры: 30 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
- 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
Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer - a Prospective Longitudinal Study
Обзор
In Europe, breast cancer is by far the most common form of cancer diagnosed in women today, accounting for 29% of all cases. The 5-year survival rate is approximately 90%. Surgery is usually combined with radiotherapy (RT), anthracyclines, aromatase inhibitors and/or trastuzumab (Herceptin) which all have improved the life expectancy and survival in breast cancer patients. Unfortunately, RT is associated with a broad spectrum of cardiovascular diseases, which includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke, and is the most common non-malignancy cause of death. During the last two decades, RT regimens for breast cancer have changed and the doses of radiation to which the heart is exposed are now potentially lower due to new and improved RT techniques. However, there are no data on whether these new regimes decrease the risk of cardiovascular disease. In this study the incidence and prevalence of cardiovascular diseases will be estimated 8 and 15 years after both conventional and laser assisted breath controlled RT, and compared with cardiovascular diseases in the general female population. A further aim is to evaluate signs and prevalence of acute cardiotoxicity from RT with the use of cardiac magnetic resonance imaging, coronary fractional flow reserve, ECG and inflammatory and cardiac biomarkers and to investigate whether these signs can predict later cardiovascular disease. The importance of traditional cardiovascular risk factors (age, hypertension, hypercholesterolemia, smoking habits and physical activity, as registered before RT) will also be evaluated.
Подробное описание
The study is an observational study. In 2007-2012 conventional RT was part of the common treatment regime for breast cancer, but has recently been replaced by laser assisted breath controlled RT. Thus, two cohorts of breast cancer patients treated with different modes of RT will be followed for the development of cardiovascular disease for the subsequent 15 years.
Первичные конечные точки
- incidence of cardiovascular disease [Срок оценки: 8 years]
- incidence of cardiovascular disease [Срок оценки: 15 years]
Критерии участия
Критерии включения
- diagnosis of breast cancer
- expected life-expectancy above 10 years
Критерии исключения
- Not willing to participate
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Норвегия · 2 центра
- Ålesund Hospital — Ålesund
- St Olavs University Hospital — Trondheim
Публикации
- Reidunsdatter RJ, Rannestad T, Frengen J, Frykholm G, Lundgren S. Early effects of contemporary breast radiation on health-related quality of life - predictors of radiotherapy-related fatigue. Acta Oncol. 2011 Nov;50(8):1175-82. doi: 10.3109/0284186X.2011.604345. Epub 2011 Aug 28. PMID 21871005
Идентификаторы
NCT: NCT02541435 · 2015/583