Prevalence of Hypogonadism in Male Cancer Patients

November 24, 2020 updated by: Marco Marcelli, Baylor College of Medicine

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male subjects with cancer and non-cancer controls

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Michael E. DeBakey VA Medical Center
Solvay Pharmaceuticals

Investigators

  • Principal Investigator: Jose M Garcia, MD, Baylor College of Medicine, Michael E. DeBakey VAMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 2, 2020

Study Completion (Actual)

September 2, 2020

Study Registration Dates

First Submitted

May 11, 2007

First Submitted That Met QC Criteria

May 11, 2007

First Posted (Estimate)

May 14, 2007

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 24, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19709

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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