Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

NCT ID: NCT00705094

Last Updated: 2014-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-07-31

Brief Summary

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For many years, researchers and doctors have studied different kinds of treatments to improve the survival of men with testicular cancer. However, recent research has shown that many years later, men who had testicular cancer appear to be at higher risk for developing heart disease (heart attack or heart failure), especially if they received chemotherapy. Since these studies were done many years after men received treatment, there was no way to know if other factors contributed to the health problems they experienced. This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.

Detailed Description

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The aim of this pilot study is to examine global and regional LV systolic and diastolic function, cardiac output, cardiac reserve, VO2peak and CVD risk profile in males recently diagnosed with testicular cancer treated with surgery alone or surgery and chemotherapy.

Conditions

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Testicular Cancer Seminoma Non-seminomatous

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Testicular cancer patients who have received surgery and are scheduled for surveillance

No interventions assigned to this group

2

Testicular cancer patients who have received surgery and are scheduled for chemotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* surgery and surveillance
* surgery and multi-cycle chemotherapy
* both good and intermediate prognosis seminoma and non-seminomatous germ cell testicular tumors
* Karnofsky performance index \> 70%
* no contraindications to cardiopulmonary testing

Exclusion Criteria

* documented cardiovascular disease or evidence of myocardial ischemia on the incremental exercise (VO2peak) test.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AHS Cancer Control Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Haykowsky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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GU-24167

Identifier Type: -

Identifier Source: org_study_id

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