Prevalence of Hypogonadism in Male Cancer Patients

This study has been completed.
Sponsor:
Collaborators:
Michael Debakey Veterans Affairs Medical Center
Solvay Pharmaceuticals
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00472940
First received: May 11, 2007
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

Cancer and its complications are common problems. In most cases, this condition has a profound impact on survival and quality of life (QoL). Fatigue, sexual dysfunction, decreased sexual drive, depression and poor appetite are commonly seen in these patients. However, these symptoms also are seen in men with other conditions including those with low testosterone levels.

The objective of this study is to determine the number of male patients with cancer that have low testosterone levels and to establish the relationship between testosterone levels and the symptoms that these patients experience.


Condition
Cancer
Hypogonadism

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Prevalence of Hypogonadism in Male Cancer Patients

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 135
Study Start Date: November 2006
  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

Male subjects with cancer and non-cancer controls

Criteria

Inclusion Criteria:

  1. Male subjects ≥ 18 years of age with histological diagnosis of cancer for cancer group.
  2. Provide written informed consent prior to screening.
  3. Histological diagnosis of cancer other than non-melanoma skin cancer for the two cancer groups.

Exclusion Criteria:

  1. Concomitant use of GH, Megestrol, Marinol, or any other anabolic agent, appetite stimulant (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feedings, or parenteral nutrition during the 3 months prior to entering the study.
  2. Participation in a clinical trial with investigational agents within 1 month of enrollment.
  3. Prior or current use of other medications that interfere with gonadal axis (androgens, estrogens, anti-androgens, etc).
  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: NCT00472940

Locations
United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Michael Debakey Veterans Affairs Medical Center
Solvay Pharmaceuticals
Investigators
Principal Investigator: Jose M Garcia, MD Baylor College of Medicine, Michael E. DeBakey VAMC
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jose M Garcia/Staff Physician adn Assistant Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00472940     History of Changes
Other Study ID Numbers: H-19709
Study First Received: May 11, 2007
Last Updated: June 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Cancer
Hypogonadism
testosterone
cachexia

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014