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Prevalence of Hypogonadism in Male Cancer Patients

Sponsor
Baylor College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00472940
Collaborator
Michael E. DeBakey VA Medical Center (U.S. Fed), Solvay Pharmaceuticals (Industry)
135
Enrollment
1
Location
166
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    135 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of Hypogonadism in Male Cancer Patients
    Study Start Date :
    Nov 1, 2006
    Actual Primary Completion Date :
    Sep 2, 2020
    Actual Study Completion Date :
    Sep 2, 2020

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Michael E. DeBakey Veterans Affairs Medical Center Houston Texas United States 77030

      Sponsors and Collaborators

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

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Marco Marcelli, Professor, Medicine-Endocrinology, Baylor College of Medicine
      ClinicalTrials.gov Identifier:
      NCT00472940
      Other Study ID Numbers:
      • H-19709
      First Posted:
      May 14, 2007
      Last Update Posted:
      Nov 27, 2020
      Last Verified:
      Nov 1, 2020
      Keywords provided by Marco Marcelli, Professor, Medicine-Endocrinology, Baylor College of Medicine
      Cancer
      Hypogonadism
      testosterone
      cachexia
      Additional relevant MeSH terms:
      Hypogonadism

      Study Results

      No Results Posted as of Nov 27, 2020