NCT02541435 Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer
| NCT ID | NCT02541435 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Olavs Hospital |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2016-11 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,600 participants in total. It began in 2016-11 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * diagnosis of breast cancer * expected life-expectancy above 10 years Exclusion Criteria: * Not willing to participate
Contact & Investigator
torgeir wethal, md phd
✉ torgeir.wethal@stolav.noJo-Åsmund Lund, md phd
STUDY CHAIR
St. Olavs Hospital
Frequently Asked Questions
Who can join the NCT02541435 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 70 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02541435 currently recruiting?
Yes, NCT02541435 is actively recruiting participants. Contact the research team at torgeir.wethal@stolav.no for enrollment information.
Where is the NCT02541435 trial being conducted?
This trial is being conducted at Ålesund, Norway, Trondheim, Norway.
Who is sponsoring the NCT02541435 clinical trial?
NCT02541435 is sponsored by St. Olavs Hospital. The principal investigator is Jo-Åsmund Lund, md phd at St. Olavs Hospital. The trial plans to enroll 1,600 participants.