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

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Principal Investigator

Stewart B Fleishman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Continuum Cancer Centers of New York


United States: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

December 2009

Related Keywords:

  • Hypogonadism
  • male
  • cancer
  • Hypogonadism



Beth Israel Medical CenterNew York, New York  10003