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.

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Key information

Conditions

Testicular Cancer Cardiovascular Diseases Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Beatson West of Scotland Cancer Centre

Glasgow, G51 4TF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histological diagnosis of stage 1 or IGCCCG5good or intermediate prognosis metastatic testicular/retroperitoneal germ cell cancer with treatment plan that includes orchidectomy or orchidectomy plus cisplatin based chemotherapy
Aged between 18 and 65 years inclusive

Exclusion criteria

Unable to provide written, informed consent
Unable or unwilling to attend for investigations
Current involvement in a clinical trial
Anti-platelet therapy at time of enrolment
Statin or other lipid-lowering therapy at time of enrolment
Recreational drug use
Ongoing inflammatory, infective or autoimmune disease
Other malignant disease diagnosed in previous 5 years
Previous venous or arterial thrombotic/thromboembolic event

Treatment and study plan

Primary outcomes

Change in flow-mediated dilatation post cisplatin based chemotherapy

Time frame: 9 months

Maximum change in flow-mediated dilatation post cisplatin based chemotherapy

Secondary outcomes

Percentage change in circulating platelet monocyte aggregates post cisplatin based chemotherapy

Time frame: 9 months

Maximum change in percentage circulating platelet monocyte aggregates post cisplatin based chemotherapy

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

University of Glasgow

Registry information

Acronym: VECTOR

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Jun 14, 2018
Registry last updated: Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed