Prevalence of Hypogonadism in Male Cancer Patients

This study is currently recruiting participants.

Verified by Baylor College of Medicine, May 2007

Sponsors and Collaborators:	Baylor College of Medicine Michael Debakey Veterans Affairs Medical Center Solvay Pharmaceuticals
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00472940

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

MedlinePlus related topics: Cancer

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title:	Prevalence of Hypogonadism in Male Cancer Patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
Participation in a clinical trial with investigational agents within 1 month of enrollment.
Prior or current use of other medications that interfere with gonadal axis (androgens, estrogens, anti-androgens, etc).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472940

Locations

United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center	Recruiting
Houston, Texas, United States, 77030
Contact: Jose M Garcia, MD 713-794-7989 jgarcia1@bcm.edu
Contact: Toni Woodson 7137947378
Principal Investigator: Jose M Garcia, MD
Sub-Investigator: Joanna Smiechowska, MD

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:

Garcia JM, Li H, Mann D, Epner D, Hayes TG, Marcelli M, Cunningham GR. Hypogonadism in male patients with cancer. Cancer. 2006 Jun 15;106(12):2583-91.

Study ID Numbers:	H-19709
Study First Received:	May 11, 2007
Last Updated:	May 11, 2007
ClinicalTrials.gov Identifier:	NCT00472940
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Cancer
Hypogonadism
testosterone
cachexia

Study placed in the following topic categories:

Testosterone
Hypogonadism
Gonadal Disorders
Endocrine System Diseases

Cachexia
Methyltestosterone
Endocrinopathy
Testosterone 17 beta-cypionate

ClinicalTrials.gov processed this record on January 14, 2009