Survey of Testosterone Levels in Male Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
Solvay Pharmaceuticals
St. Luke's-Roosevelt Hospital Center
Christiana Care Health Services
Information provided by:
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00483418
First received: June 6, 2007
Last updated: March 10, 2011
Last verified: March 2011
  Purpose

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.


Condition
Hypogonadism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Survey of Testosterone Levels in a Diverse Set of Male Patients With Hormone-Independent Cancers

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Enrollment: 425
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483418

Locations
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Sponsors and Collaborators
Beth Israel Medical Center
Solvay Pharmaceuticals
St. Luke's-Roosevelt Hospital Center
Christiana Care Health Services
Investigators
Principal Investigator: Stewart B Fleishman, MD Continuum Cancer Centers of New York
  More Information

No publications provided

Responsible Party: Victoria Rosenwald RN MPH, Beth Israel Oncology Research Office
ClinicalTrials.gov Identifier: NCT00483418     History of Changes
Other Study ID Numbers: 062-07
Study First Received: June 6, 2007
Last Updated: March 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
male
cancer

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014