Clinical trial NCT02541435: Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer
Official title: Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer - a Prospective Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Cardiovascular Diseases
Keywords: Radiotherapy
Biological markers
Magnetic resonance imaging
Echocardiography
Tomography, X-Ray Computed
Risk factors
Heart
Quality of Life
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Alesund Hospital
First posted: 2015-09-04
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women treated for breast cancer with radiotherapy

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Not willing to participate

Primary outcomes:
measure: incidence of cardiovascular disease
timeFrame: 8 years
measure: incidence of cardiovascular disease
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs University Hospital
city: Ålesund
country: Norway
facility: Ålesund Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Jo-Åsmund Lund, md phd
role: STUDY_CHAIR
References:
citation: 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.