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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-70
SponsorSt. Olavs Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of breast cancer

expected life-expectancy above 10 years

Disqualifiers

Not willing to participate

Trial population

women treated for breast cancer with radiotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,600 Participants
are grouped into 3 trial groups
Group A: conventional radiotherapy
Group B: breath controlled radiotherapy
Group C: controls

Trial outcomes

Primary outcomes

1

incidence of cardiovascular disease

compared with corresponding estimates from the female general population (HUNT-registry data, age-matched sample)

Time frame
8 years
2

incidence of cardiovascular disease

compared with corresponding estimates from the female general population (HUNT-registry data, age-matched sample)

Time frame
15 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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St. Olavs Hospital

Lead sponsor

Norwegian University of Science and Technology

Collaborator

Alesund Hospital

Collaborator