Survey of Testosterone Levels in Male Cancer Patients

Hypogonadism Clinical Trial

Official title:

Survey of Testosterone Levels in a Diverse Set of Male Patients With Hormone-Independent Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483418
• Other study ID #: 062-07
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: March 10, 2011
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hypogonadism

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Beth Israel Medical Center	Christiana Care Health Services, Solvay Pharmaceuticals, St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States,