Clinical trial NCT00483418: Survey of Testosterone Levels in Male Cancer Patients
Official title: Survey of Testosterone Levels in a Diverse Set of Male Patients With Hormone-Independent Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Keywords: male
cancer
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
name: St. Luke's-Roosevelt Hospital Center
name: Christiana Care Health Services
First posted: 2007-06-07
Enrollment: 425
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with non-hormone dependent cancers who are having blood drawn for other purposes before 12 noon.

Brief 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Continuum Cancer Centers of New York
name: Stewart B Fleishman, MD
role: PRINCIPAL_INVESTIGATOR
References: