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Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer

Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer - a Prospective Longitudinal Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02541435
Enrollment
1600
Registered
2015-09-04
Start date
2016-11-01
Completion date
2036-12-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Cardiovascular Diseases

Keywords

Radiotherapy, Biological markers, Magnetic resonance imaging, Echocardiography, Tomography, X-Ray Computed, Risk factors, Heart, Quality of Life

Brief summary

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.

Interventions

None listed

Sponsors

St. Olavs Hospital
Lead SponsorOTHER
Norwegian University of Science and Technology
CollaboratorOTHER
Alesund Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* diagnosis of breast cancer * expected life-expectancy above 10 years

Exclusion criteria

* Not willing to participate

Design outcomes

Primary

MeasureTime frameDescription
incidence of cardiovascular disease8 yearscompared with corresponding estimates from the female general population (HUNT-registry data, age-matched sample)

Countries

Norway

Contacts

CONTACTtorgeir wethal, md phd
torgeir.wethal@stolav.no
CONTACTJo-Åsmund Lund, md phd
jo-asmund.lund@stolav.no
STUDY_CHAIRJo-Åsmund Lund, md phd

St. Olavs Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026