Cardiovascular Diseases Clinical Trial
Official title:
Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer
incidence is increasing1,2. Whilst the prognosis is very good with the vast majority of
patients cured with orchidectomy alone, those with high risk stage one non seminomatous germ
cell cancer (NSCGT) or metastatic disease (NSCGT or seminoma) are treated by surgery followed
by chemotherapy. Platinum based chemotherapy is associated with long-term cardiovascular
sequelae.
Endothelial dysfunction is a key component of early atherogenesis and the later stages of
obstructive atherosclerosis, plaque rupture and thrombus formation. Whilst endothelial toxic
effects of BEP chemotherapy appear to be central in the pathophysiology of associated
complications, abnormalities in endothelial function as assessed by measures of brachial
artery flow-mediated dilatation (FMD) have not demonstrated a consistent effect over time.
When assessed within ten weeks of platinum-based chemotherapy9, no change in FMD was observed
whilst marked decreases are seen immediately following treatment11 and also one year
following treatment12. Therefore, the time-course of endothelial vasomotor impairment remains
incompletely defined in a single prospective cohort.
There remains an unmet need to identify a preventive treatment for patients with testicular
cancer treated with platinum based chemotherapy to diminish the substantial risk of
subsequent cardiovascular events. A future randomised trial of statin therapy in these
patients is under consideration and results from this pilot study will inform its design.
Before moving towards interventional studies the proposed pilot study will enable a better
understanding of the nature, time-course and dose-dependent effects of the mechanisms
contributing to increased cardiovascular risk.
Single-centre, prospective pilot study assessing the cardiovascular effects of treatment with
orchidectomy or orchidectomy plus cisplatin based chemotherapy for testicular cancer.
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