Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms, Cardiovascular Diseases. Basic parameters: 30 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer - a Prospective Longitudinal Study
Overview
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.
Detailed description
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.
Primary outcome measures
- incidence of cardiovascular disease [Time frame: 8 years]
- incidence of cardiovascular disease [Time frame: 15 years]
Eligibility criteria
Inclusion criteria
- diagnosis of breast cancer
- expected life-expectancy above 10 years
Exclusion criteria
- Not willing to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Norway · 2 centers
- Ålesund Hospital — Ålesund
- St Olavs University Hospital — Trondheim
Publications
- 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
Identifiers
NCT: NCT02541435 · 2015/583