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Survey of Testosterone Levels in Male Cancer Patients
This study is currently recruiting participants.
Verified by Beth Israel Medical Center, May 2008
Sponsors and Collaborators: Beth Israel Medical Center
Solvay Pharmaceuticals
St. Luke's-Roosevelt Hospital Center
University of Iowa
University of Delaware
Ohio State University
Information provided by: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00483418
  Purpose

The purpose of this study is to survey the total serum testosterone levels in male patients with hormone-independent malignancies. The prevalence of hypogonadism is not known, but is thought to be significant. Results will be adjusted for age and stratified for type of cancer, stage, study site,and presence of opiate use for pain management, which is known to reduce testosterone levels.


Condition
Hypogonadism

MedlinePlus related topics: Cancer
Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Cross-Sectional
Official Title: Survey of Testosterone Levels in a Diverse Set of Male Patients With Hormone-Independent Cancers

Further study details as provided by Beth Israel Medical Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 412
Study Start Date: June 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Fatigue - extreme tiredness - is associated with cancer as well as its treatment. It has many causes, including the direct effects of the cancer itself, nutritional changes, anemia, changes in activity levels, worry, or, perhaps, hormones such as testosterone. This study is a survey of the amount of testosterone in the blood of men being treated for cancers that are not directly influenced by testosterone (not prostate or testicular tumors).

Testosterone is a hormone that is made by the body from teenage years through adulthood, and helps define male characteristics: sexual function, muscle building, ability to grow hair and deepen the voice. It is believed that the amount of fatigue experienced by men with cancer may be at least and in part due to reduced testosterone levels.

Male cancer patients will be recruited for this study at the time of regularly scheduled visits with their oncologists for treatment or for follow-up care. Patients who agree to participate and sign a consent will be asked to answer questions about their health, medications, vitamins & supplements, and to complete a standardized questionnaire about their quality of life. One tube of blood (8.5 cc) will be drawn at the same time as the other blood tests scheduled for that visit to avoid an additional blood draw. Various elements of the collected information will be compared with the testosterone levels to see if any meaningful patterns exist. The study sample will be drawn from a geographically diverse set of oncology practices in the US. A larger follow-up study is planned if testosterone levels are found to be lower in men with cancer than similar age men without cancer, or if low testosterone levels are associated with more fatigue.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Men with non-hormone dependent cancers who are having blood drawn for other purposes before 12 noon.

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Male Cancer patients coming to oncology appointments for treatment or follow-up
  • Must be able to answer questionnaire in english, alone or with assistance
  • Informed consent

Exclusion Criteria:

  • Known HIV infection
  • Known hypogonadism
  • testosterone or DHEA supplementation within 3 months
  • prostate, breast, or testicular cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483418

Contacts
Contact: Victoria Rosenwald, RN MPH 212 844-8285 vrosenwa@chpnet.org
Contact: Stewart B Fleishman, MD 212 844-6295 sfleishm@chpnet.org

Locations
United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Contact: vr121@columbia.edu     212-844-8285     vr121@columbia.edu    
Contact: Victoria Rosenwald     212-844-8285     vr121@columbia.edu    
Sub-Investigator: Victoria Rosenwald            
Sponsors and Collaborators
Beth Israel Medical Center
Solvay Pharmaceuticals
St. Luke's-Roosevelt Hospital Center
University of Iowa
University of Delaware
Ohio State University
Investigators
Principal Investigator: Stewart B Fleishman, MD Continuum Cancer Centers of New York
  More Information

Responsible Party: Beth Israel Oncology Research Office ( Victoria Rosenwald RN MPH )
Study ID Numbers: 062-07
Study First Received: June 6, 2007
Last Updated: May 7, 2008
ClinicalTrials.gov Identifier: NCT00483418  
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
male
cancer

Study placed in the following topic categories:
Testosterone
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Endocrinopathy
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 14, 2009