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CompletedNCT00483418Updated Mar 11, 2011

Survey of Testosterone Levels in Male Cancer Patients

An observational study in Hypogonadism, sponsored by Beth Israel Medical Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-11.

Sponsored by Beth Israel Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
425
Ages
18 Years and older
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Hypogonadism

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Keywords

  • male
  • cancer
03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's enrollment of 425 is above the median of 96 across 66 observational studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

Beth Israel Medical Center is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Known HIV infection
  • Known hypogonadism
  • testosterone or DHEA supplementation within 3 months
  • prostate, breast, or testicular cancer
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
425 participants (actual)
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Study locations

1 site
  • Beth Israel Medical Center
    New York, New York 10003, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00483418
Lead sponsor
Beth Israel Medical Center
Collaborators
Solvay Pharmaceuticals, St. Luke's-Roosevelt Hospital Center, Christiana Care Health Services
First posted
Jun 7, 2007
Start date
Jun 2007
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Mar 11, 2011

Study contacts

Stewart B Fleishman, MD
principal investigator · Continuum Cancer Centers of New York

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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