Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

Completed

• Conditions: Hypogonadism; Metabolic Syndrome; Cardio-vascular Disease

• Registration Number: NCT02240966
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-12
• Study First Posted: 2014-09-16
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-13
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark