Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients - Full Text View

Sponsor:	Alberta Health Services
Information provided by:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00705094

Purpose

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.

Condition
Testicular Cancer Seminoma Non-seminomatous

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Testicular Cancer

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	November 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Testicular cancer patients who have received surgery and are scheduled for surveillance
2 Testicular cancer patients who have received surgery and are scheduled for chemotherapy

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

testicular cancer patients who have recieved surgery and are scheduled for either chemotherapy or surveillance

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705094

Locations

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2

Sponsors and Collaborators

Alberta Health Services

Investigators

Principal Investigator:

Mark Haykowsky, PhD

University of Alberta

More Information

No publications provided

Responsible Party:	Mark Haykowsky, PhD, University of Alberta
ClinicalTrials.gov Identifier:	NCT00705094 History of Changes
Other Study ID Numbers:	GU-24167
Study First Received:	June 23, 2008
Last Updated:	August 11, 2011
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by Alberta Health Services:

cardiovascular risk factors
cardiac function
VO2peak
Chemotherapy

Additional relevant MeSH terms:

Seminoma
Testicular Neoplasms
Germinoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms

Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 09, 2012