The primary objective is to explore endothelial function in patients before and after treatment with anthracyclines.
ID
Source
Brief title
Condition
- Heart failures
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endothelial function is measured by reactive hyperemia index (RHI) with a
peripheral arterial tonometry (PAT).
Secondary outcome
Demographics, cardiovascular risk factors, medical history, oncological
treatment protocol will be obtained from the patient file which is used at the
outpatient clinic.
Background summary
Cardiotoxicity is a feared side-effects of anticancer treatment, and negatively
influences the quality of life of patients who benefit from improvements in
anticancer treatment. Particularly, anthracyclines and trastuzumab are known
for their chance of causing cardiac dysfunction. The underlying mechanisms of
cardiotoxicity are partially elucidated. Questions still remain which patients
will suffer from this side effect. The role of endothelial dysfunction in
cancer therapy-related cardiac dysfunction (CTRCD), has not been fully
established yet. This study forms the first step in the research of endothelial
dysfunction and cancer therapy-related cardiac dysfunction.
Study objective
The primary objective is to explore endothelial function in patients before and
after treatment with anthracyclines.
Study design
Prospective observational study.
Study burden and risks
The measurement of RH-PAT will be performed with the EndoPAT2000, which is a
non-invasive and safe diagnostic tool. The main burden for patients is a five
minute blood flow occlusion through blood pressure cuff inflation, which gives
an unpleasant feeling and might cause slight bruising. The measurement will be
performed during a visit to the outpatient clinic. No extra visit or physical
examination is required. The study will not affect the treatment of the
patients.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Female
- Age >=18 years
- Histological proven breast cancer
- Planned treatment: a chemotherapeutic regimen containing anthracyclines.
Exclusion criteria
Patients who are unable to fasten 3 hours prior to the measurement
- Prior treatment with chemotherapy which contained anthracyclines, platinum derivates or bleomycin.
- Prior treatment with high dose chest radiation (i.e. >20Gy)
- Possible confounders on endothelial function
o Current smokers and patients who quitted smoking < 2 years ago.
o Patients with known vascular disease (e.g. symptomatic peripheral or coronary artery disease)
o Patients with Diabetes Mellitus
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62497.041.17 |