Prevalence of Hypogonadism in Male Cancer Patients

NCT00472940 | Completed DMC

• 1 other identifier: H-19709
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Hypogonadism

Keywords

Cancer; Hypogonadism; testosterone; cachexia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male subjects with cancer and non-cancer controls

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Michael E. DeBakey VA Medical Center: collaborator
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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. doi: 10.1002/cncr.21889.

  PMID: 16688773 BACKGROUND

• Burney BO, Hayes TG, Smiechowska J, Cardwell G, Papusha V, Bhargava P, Konda B, Auchus RJ, Garcia JM. Low testosterone levels and increased inflammatory markers in patients with cancer and relationship with cachexia. J Clin Endocrinol Metab. 2012 May;97(5):E700-9. doi: 10.1210/jc.2011-2387. Epub 2012 Mar 14.

  PMID: 22419719 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Neoplasms; Hypogonadism; Cachexia

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Jose M Garcia, MD

  Baylor College of Medicine, Michael E. DeBakey VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine-Endocrinology

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 14, 2007
• Study Start: November 1, 2006
• Primary Completion: September 2, 2020
• Study Completion: September 2, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

US (1)