Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer
NCT ID: NCT02541435
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1600 participants
OBSERVATIONAL
2016-11-30
2036-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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conventional radiotherapy
450 breast cancer patients treated with conventional radiotherapy with or without anthracyclines and/or trastuzumab during 2007-2012
No interventions assigned to this group
breath controlled radiotherapy
350 breast cancer patients treated with laser assisted breath controlled radiotherapy with or without anthracyclines and/or trastuzumab during 2015-2017
No interventions assigned to this group
controls
per participating patient 2 age-matched female controls from the HUNT-3 population (total 800)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* expected life-expectancy above 10 years
Exclusion Criteria
30 Years
70 Years
FEMALE
No
Sponsors
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Norwegian University of Science and Technology
OTHER
Alesund Hospital
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Jo-Åsmund Lund, md phd
Role: STUDY_CHAIR
St. Olavs Hospital
Locations
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Ålesund Hospital
Ålesund, , Norway
St Olavs University Hospital
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2015/583
Identifier Type: -
Identifier Source: org_study_id
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