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Completed

NCT Number: NCT02240966

Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

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

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Key information

Conditions

Metabolic Syndrome Cardio-vascular Disease Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Insulin Resistance Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Lean body mass (Kilogram)

    Time frame: Up to 12 months

    Lean body mass assessed by DXA-scan

  2. Bone Mineral Density (Gram/cm2)

    Time frame: Up to 12 months

    Bone mineral density assessed by DXA-scan

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

    Time frame: Up to 12 months

  4. Renal function (Glomerular Filtration Rate ml/min)

    Time frame: Up to 12 months

    Renal function is assessed with 51Cr-EDTA

  5. Fasting Blood Glucose

    Time frame: Up to 12 months

  6. plasma-insulin

    Time frame: Up to 12 months

  7. Adiponectin and leptin

    Time frame: Up to 12 months

  8. Ultrasonic appearance and size of the remaining testicle

    Time frame: Up to 12 months

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

  9. Quality of life

    Time frame: Up to 12 months

    Quality of Life is assessed by the EORTC QLQ-30 Questionnaire

  10. Anxiety and depression

    Time frame: Up to 12 months

    Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS)

  11. Fatigue

    Time frame: Up to 12 months

    Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2014
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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