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

Sponsor
NHS Greater Glasgow and Clyde (Other)
Overall Status
Completed
CT.gov ID
NCT03557177
Collaborator
University of Glasgow (Other)
36
Enrollment
1
Location
21.9
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    36 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer
    Actual Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    Jul 1, 2018
    Actual Study Completion Date :
    Jul 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Change in flow-mediated dilatation post cisplatin based chemotherapy [9 months]

      Maximum change in flow-mediated dilatation post cisplatin based chemotherapy

    Secondary Outcome Measures

    1. Percentage change in circulating platelet monocyte aggregates post cisplatin based chemotherapy [9 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beatson West of Scotland Cancer Centre Glasgow United Kingdom G51 4TF

    Sponsors and Collaborators

    • NHS Greater Glasgow and Clyde
    • University of Glasgow

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NHS Greater Glasgow and Clyde
    ClinicalTrials.gov Identifier:
    NCT03557177
    Other Study ID Numbers:
    • GN15CA467
    First Posted:
    Jun 14, 2018
    Last Update Posted:
    Nov 25, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NHS Greater Glasgow and Clyde
    cisplatin
    flow mediated dilatation
    Additional relevant MeSH terms:
    Testicular Neoplasms
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Nov 25, 2019