Prevalence of Hypogonadism in Male Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2020-09-02

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Hypogonadism

Keywords

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Cancer Hypogonadism testosterone cachexia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Marco Marcelli

Professor, Medicine-Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose M Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine, Michael E. DeBakey VAMC

Locations

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Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 16688773 (View on PubMed)

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.

Reference Type DERIVED

PMID: 22419719 (View on PubMed)

Other Identifiers

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H-19709

Identifier Type: -

Identifier Source: org_study_id