Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer (VECTOR)

November 22, 2019 updated by: NHS Greater Glasgow and Clyde

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Beatson West of Scotland Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Orchidectomy alone or Orchidectomy plus 1-2 cycles adjuvant cisplatin based chemotherapy or Orchidectomy plus 3-4 cycles cisplatin based chemotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in flow-mediated dilatation post cisplatin based chemotherapy
Time Frame: 9 months
Maximum change in flow-mediated dilatation post cisplatin based chemotherapy
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow

Investigators

  • Principal Investigator: Ninian Lang, MBChB PhD, QEUH, NHS Greater Glasgow and Clyde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 22, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN15CA467

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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