Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

Testicular Cancer Clinical Trial

Official title:

Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705094
• Other study ID #: GU-24167
• Status: Completed
• Phase: N/A
• First received: June 23, 2008
• Last updated: September 29, 2014
• Start date: September 2008
• Est. completion date: July 2012

Study information

• Verified date: September 2014
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Non-seminomatous
• Seminoma
• Testicular Cancer
• Testicular Neoplasms

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada,