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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

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 - TOXTAC

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34932
Enrollment
150
Registered
2010-09-22
Start date
2010-11-15
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac injury cardiotoxicity

Interventions

None listed

Sponsors

Integraal Kankercentrum Oost
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
left ventricular ejection fraction

Secondary

MeasureTime frame
-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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)