Survey of Testosterone Levels in Male Cancer Patients

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.

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Key information

Conditions

Hypogonadism Endocrine System Diseases Gonadal Disorders Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Beth Israel Medical Center

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Beth Israel Medical Center

Other

Collaborators

Christiana Care Health Services
Solvay Pharmaceuticals
St. Luke's-Roosevelt Hospital Center

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jun 7, 2007
Registry last updated: Mar 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed