1. To detect subclinical cardiovascular damage in adults patients with breast cancer who have completed treatment with TAC at least one year previously at least one year previously, using MIBG scintigraphy, novel echocardiographic techniques and…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
left ventricular ejection fraction
Secondary outcome
-clinical symptoms or signs of heart failure (tachycardia, dyspnea, orthopnea,
edema, S3 gallop)
-other echocardiographic parameters to indicate systolic and diastolic
function, left ventricular dimension and left ventricular mass
-electrocardiographical signs of ischemia or arrhytmia
-MIBG uptake below normal
-Troponin-I, NT-pro-BNP, cytokine and adhesion molecule levels above normal
Background summary
Cardiovascular toxicity is one of the most devastating complications of cancer
treatment and can arise during or shortly after treatment, or even several
years later. Especially anthracyclines have dose-limiting cardiac toxicity and
can result in congestive heart failure and cardiomyopathy years after
administration. Few studies have measured cardiovascular toxicity in long-term
breast cancer survivors exposed to anthracycline adjuvant therapy. No data are
available on the long-term cardiovascular effect of the combination of
docetaxel, doxorubicin and cyclophosphamide. As measurement of left ventricular
ejection fraction underestimates cardiac damage, additional strategies for the
monitoring of treatment-induced cardiotoxicity need to be explored.
Study objective
1. To detect subclinical cardiovascular damage in adults patients with breast
cancer who have completed treatment with TAC at least one year previously at
least one year previously, using MIBG scintigraphy, novel echocardiographic
techniques and blood biomarkers.
2. To assess the predictive value at baseline of MIBG scintigraphy, novel
echocardiographic techniques and blood biomarkers for the development of
clinically overt heart failure (New York Heart Association Classification II,
III, or IV) five years and ten years after treatment with TAC.
3. To assess the predictive value at baseline of MIBG scintigraphy, novel
echocardiographic techniques and blood biomarkers for further deterioration of
subclinical cardiotoxicity five years and ten years after treatment
Study design
Non-randomized single centre follow up cohort study
Study burden and risks
Risks associated with participation:
Not applicable, there are no risks associated with participation.
Burden:
It is a burden in terms of time (circa one whole day).
Benefit and group relatedness:
There is no benefit for the participating patients.
There might be a benefit for similar patients in the future:
It is important to detect and prevent cardiac morbidity and mortality in an
early stage. This provides the opportunity to timely change to other cancer
treatments or other dosage schedules, other combinations, or to add
ameliorating agents. This study can also provide significant insights into the
mechanisms and pathophysiology of cardiotoxicity caused by the huge number of
anti-cancer agents and agents in development.
Theodoor Craanenlaan 11
6525 GH Nijmegen
NL
Theodoor Craanenlaan 11
6525 GH Nijmegen
NL
Listed location countries
Age
Inclusion criteria
-Female patients with breast cancer, >= 18 years old at the time of breast cancer diagnosis
-(Neo)adjuvant treatment with docetaxel, doxorubicin and cyclophosphamide (TAC) completed minimally one year before inclusion and maximally nine years before.
Exclusion criteria
-Evidence of breast cancer recurrence or metastatic disease
-Evidence of heart disease at the time of breast cancer diagnosis
-Evidence of renal failure at the time of cardiac evaluation
-Pregnant or lactating
-Participation in a research protocol with ionizing radiation within one year before inclusion.
-Evidence of Diabetes Mellitus or Parkinson*s Disease
-Evidence of an MIBG-accumulating tumor
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 | NL31859.091.10 |