Actively Recruiting

Age: 30Years - 70Years
FEMALE
NCT02541435

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

Led by St. Olavs Hospital · Updated on 2025-03-13

1600

Participants Needed

2

Research Sites

1047 weeks

Total Duration

On this page

Sponsors

S

St. Olavs Hospital

Lead Sponsor

N

Norwegian University of Science and Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 30Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of breast cancer
  • Expected life expectancy above 10 years
Not Eligible

You will not qualify if you...

  • Not willing to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Ålesund Hospital

Ålesund, Norway

Actively Recruiting

2

St Olavs University Hospital

Trondheim, Norway

Actively Recruiting

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Research Team

T

torgeir wethal, md phd

CONTACT

J

Jo-Åsmund Lund, md phd

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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