Clincosm LogoSign in Get a demo

INTELLECT: Intermediate and Long Term Vascular Effects of Cisplatin in Patients With Testicular Cancer

Sponsor
NHS Greater Glasgow and Clyde (Other)
Overall Status
Completed
CT.gov ID
NCT03557164
Collaborator
University of Glasgow (Other)
37
Enrollment
1
Location
16
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chemotherapy drugs improve cancer survival but increase the risk of cardiovascular disease (CVD). VEGF inhibitors (VEGFI) cause severe hypertension, while cisplatin appears pro-thrombotic. Hence while cancer survival may improve, this is at the risk of potentially severe CVD and associated morbidity. Mechanisms underlying the cardiovascular toxicities of VEGFI and cisplatin are unknown, but effects on vascular function may be important.

The INTELLECT study will phenotype the endothelial effects of VEGFI and cisplatin using a variety of methods.

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 risk of subsequent cardiovascular events. A future randomised trial of statin therapy in these patients is under consideration and results from this study will inform its design.

    The information gained from this pilot study will guide the development of interventional pharmacological studies that are directed towards the most appropriate pathophysiological processes, at the most appropriate time and in the most appropriate patient groups treated with platinum based chemotherapy for testicular cancer.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    37 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Intermediate and Long Term Vascular Effects of Cisplatin in Patients With Testicular Cancer
    Actual Study Start Date :
    Mar 1, 2017
    Actual Primary Completion Date :
    Jul 1, 2018
    Actual Study Completion Date :
    Jul 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. venous occlusion plethysmography assessment of endothelial function [8 weeks]

      expressed as ml per 100 ml of forearm volume per minute

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histological diagnosis of stage 1 low-risk germ cell testicular cancer treated with orchidectomy, or IGCCC good or intermediate prognosis metastatic testicular/retroperitoneal germ cell cancer treated with orchidectomy (and or retroperitoneal surgery) plus cisplatin based chemotherapy, 12 - 18 months or 5 - 7 years previously.

    • Aged between 18 and 50 years inclusive, at time of enrolment

    Exclusion Criteria:

    • Unable to provide written, informed consent

    • Unable or unwilling to attend for investigations

    • Current active involvement in a clinical trial

    • Those receiving drug treatment for any vascular disease:

    o Including hypertension, hyperlipidaemia, cerebrovascular disease, ischaemic heart disease or heart failure

    • Asthma

    • Chronic obstructive pulmonary disease

    • Diabetes mellitus

    • Arial fibrillation/flutter

    • Oral anticoagulation therapy

    • Cigarette smoker or tobacco use

    • Recreational drug use

    • Ongoing inflammatory, infective or autoimmune disease

    • Other malignant disease diagnosed in previous 7 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 G12 0YN

    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:
    NCT03557164
    Other Study ID Numbers:
    • 16/WS/0030
    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
    Additional relevant MeSH terms:
    Testicular Neoplasms
    Cardiovascular Diseases

    Study Results

    No Results Posted as of Nov 25, 2019