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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 70
Healthy Volunteers: f
View:

• diagnosis of breast cancer

• expected life-expectancy above 10 years

Locations
Other Locations
Norway
Ålesund Hospital
RECRUITING
Ålesund
St Olavs University Hospital
RECRUITING
Trondheim
Contact Information
Primary
torgeir wethal, md phd
torgeir.wethal@stolav.no
Backup
Jo-Åsmund Lund, md phd
jo-asmund.lund@stolav.no
Time Frame
Start Date: 2016-11
Estimated Completion Date: 2036-12
Participants
Target number of participants: 1600
Treatments
conventional radiotherapy
450 breast cancer patients treated with conventional radiotherapy with or without anthracyclines and/or trastuzumab during 2007-2012
breath controlled radiotherapy
350 breast cancer patients treated with laser assisted breath controlled radiotherapy with or without anthracyclines and/or trastuzumab during 2015-2017
controls
per participating patient 2 age-matched female controls from the HUNT-3 population (total 800)
Sponsors
Leads: St. Olavs Hospital
Collaborators: Alesund Hospital, Norwegian University of Science and Technology

This content was sourced from clinicaltrials.gov