MIBG scintigraphy and Strain Echocardiography in the early detection of late cardiovascular effects of (neo)adjuvant breast cancer treatment with docetaxel, doxorubicin and cyclophosphamide (TAC): a pilot study

Phase 4

Recruiting

Conditions: cardiac injury
cardiotoxicity
10082206

Registration Number: NL-OMON34932

Lead Sponsor: Integraal Kankercentrum Oost

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>left ventricular ejection fraction</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-clinical symptoms or signs of heart failure (tachycardia, dyspnea, orthopnea,<br /><br>edema, S3 gallop)<br /><br>-other echocardiographic parameters to indicate systolic and diastolic<br /><br>function, left ventricular dimension and left ventricular mass<br /><br>-electrocardiographical signs of ischemia or arrhytmia<br /><br>-MIBG uptake below normal<br /><br>-Troponin-I, NT-pro-BNP, cytokine and adhesion molecule levels above normal</p><br>