Clinical trial NCT02240966: Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
Official title: Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Hypogonadism
Cardio-vascular Disease
Keywords: Testicular Neoplasms
Hypogonadism
Metabolic Syndrome
Treatment related late effects
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Testicular cancer survivors

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 12 months
Secondary outcomes:
measure: Lean body mass (Kilogram)
timeFrame: Up to 12 months
measure: Bone Mineral Density (Gram/cm2)
timeFrame: Up to 12 months
measure: Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide
timeFrame: Up to 12 months
measure: Renal function (Glomerular Filtration Rate ml/min)
timeFrame: Up to 12 months
measure: Fasting Blood Glucose
timeFrame: Up to 12 months
measure: plasma-insulin
timeFrame: Up to 12 months
measure: Adiponectin and leptin
timeFrame: Up to 12 months
measure: Ultrasonic appearance and size of the remaining testicle
timeFrame: Up to 12 months
measure: Quality of life
timeFrame: Up to 12 months
measure: Anxiety and depression
timeFrame: Up to 12 months
measure: Fatigue
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Gedske Daugaard, DMSc
role: STUDY_DIRECTOR
References:
citation: Bandak M, Jorgensen N, Juul A, Lauritsen J, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Leydig cell dysfunction, systemic inflammation and metabolic syndrome in long-term testicular cancer survivors. Eur J Cancer. 2017 Oct;84:9-17. doi: 10.1016/j.ejca.2017.07.006. Epub 2017 Jul 31.
citation: Bandak M, Jorgensen N, Juul A, Lauritsen J, Kier MGG, Mortensen MS, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Reproductive hormones and metabolic syndrome in 24 testicular cancer survivors and their biological brothers. Andrology. 2017 Jul;5(4):718-724. doi: 10.1111/andr.12355. Epub 2017 Jun 9.