Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

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

Detailed Description
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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.

Official Title
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Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

Conditions
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Metabolic Syndrome, Hypogonadism, Cardio-vascular Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass (Kilogram) | Lean body mass assessed by DXA-scan | Up to 12 months | 
| Bone Mineral Density (Gram/cm2) | Bone mineral density assessed by DXA-scan | Up to 12 months | 
| Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide |  | Up to 12 months | 
| Renal function (Glomerular Filtration Rate ml/min) | Renal function is assessed with 51Cr-EDTA | Up to 12 months | 
| Fasting Blood Glucose |  | Up to 12 months | 
| plasma-insulin |  | Up to 12 months | 
| Adiponectin and leptin |  | Up to 12 months | 
| Ultrasonic appearance and size of the remaining testicle | Ultrasonic appearance and size of the remaining of testicle assessed by ultrasound | Up to 12 months | 
| Quality of life | Quality of Life is assessed by the EORTC QLQ-30 Questionnaire | Up to 12 months | 
| Anxiety and depression | Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS) | Up to 12 months | 
| Fatigue | Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20) | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testicular Neoplasms, Hypogonadism, Metabolic Syndrome, Treatment related late effects