Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

Rigshospitalet, Denmark200 enrolled

Overview

The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.

Recent studies have shown that metabolic syndrome is common among testicular cancer. Patients with low levels of testosterone appear to be at higher risk of metabolic syndrome. A substantial number of testicular cancer survivors might be in a state of "compensated hypogonadism" with testosterone levels low in the normal range due to an increased LH-drive from the pituitary gland. Whether this specific groups of testicular cancer survivors are at increased risk of cardio-vascular disease and might benefit from testosterone substitution is yet to be clarified.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Metabolic Syndrome Hypogonadism Cardio-vascular Disease

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Earlier treatment of testicular germ cell cancer * No sign of relapse \> 1 year since latest treatment * Testosterone \< 12 nmol/L and luteinizing hormone \> 8 IE/L OR * Testosterone \> 12 nmol/L and LH \> 8 IE/L OR * Testosterone and LH within their normal ranges Exclusion Criteria: * Testosterone substitution

Locations (1)

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Prevalence of Metabolic Syndrome in the three groups of testicular cancer survivors according to International Diabetes Federation Guidelines and US National Cholesterol Education Program Adult Treatment Panel III criteria

Time frame: Up to 12 months

Secondary Outcomes

Lean body mass (Kilogram)

Lean body mass assessed by DXA-scan

Time frame: Up to 12 months

Bone Mineral Density (Gram/cm2)

Bone mineral density assessed by DXA-scan

Time frame: Up to 12 months

Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide

Time frame: Up to 12 months

Renal function (Glomerular Filtration Rate ml/min)

Renal function is assessed with 51Cr-EDTA

Time frame: Up to 12 months

Fasting Blood Glucose

Time frame: Up to 12 months

plasma-insulin

Time frame: Up to 12 months

Adiponectin and leptin

Time frame: Up to 12 months

Ultrasonic appearance and size of the remaining testicle

Ultrasonic appearance and size of the remaining of testicle assessed by ultrasound

Time frame: Up to 12 months

Quality of life

Data from ClinicalTrials.gov

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