Vascular Effects of Chemotherapy for Testicular Cancer
Research type
Research Study
Full title
Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients with Testicular Cancer
IRAS ID
191027
Contact name
Ninian N Lang
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
Testicular cancer is the most common cancer in men aged 20 to 40. The prognosis is very good, although those with high risk disease or metastatic spread receive surgery followed by chemotherapy regimens associated with long-term cardiovascular side effects. Chemotherapy cycles consist of bleomycin, etoposide and cisplatin (BEP) and last 20 days. Patients receive up to 4 cycles depending on the extent of their disease.
BEP chemotherapy is associated with long-term cardiovascular side effects, thought mainly to be related to the platinum containing agent, cisplatin. There is a five-fold increased risk of cardiovascular death in the first year and a seven-fold increased long-term risk of major cardiovascular events. Patients are also predisposed to hyperlipidaemia, hypertension and a metabolic syndrome.
Endothelial dysfunction is central to the development of cardiovascular side effects associated with BEP chemotherapy. Endothelial dysfunction can be assessed using flow-mediated dilatation (FMD), which measures brachial artery responses to blood flow, with greater responses representing healthier vascular function. The time course of changes in endothelial function associated with BEP chemotherapy remains incompletely defined. There is a marked reduction in FMD immediately following treatment and at 1 year, although no change at 10 weeks. There may therefore be partially reversible early changes followed by partial recovery and a subsequent decline in endothelial function over time. The dose effects of cisplatin on endothelial function are also inadequately defined.
We wish to examine the nature, time course and dose-dependent cardiovascular effects of cisplatin based chemotherapy for testicular cancer. A randomised trial of statin therapy is under consideration in these patients and results from this pilot study will help inform its design. It will allow us to direct pharmacological interventions towards the most appropriate pathophysiological processes, at the most appropriate time and in the most appropriate patient groups treated with cisplatin based chemotherapy for testicular cancer.
REC name
West of Scotland REC 4
REC reference
15/WS/0249
Date of REC Opinion
16 Nov 2015
REC opinion
Favourable Opinion