Symptoms and Clinical Signs of Hypogonadism in Testicular Cancer Survivors

July 13, 2016 updated by: Mikkel Bandak, Rigshospitalet, Denmark
The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Testicular cancer survivors

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lean body mass (Kilogram)
Time Frame: Up to 12 months
Lean body mass assessed by DXA-scan
Up to 12 months
Bone Mineral Density (Gram/cm2)
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
Up to 12 months
Renal function (Glomerular Filtration Rate ml/min)
Time Frame: Up to 12 months
Renal function is assessed with 51Cr-EDTA
Up to 12 months
Fasting Blood Glucose
Time Frame: Up to 12 months
Up to 12 months
plasma-insulin
Time Frame: Up to 12 months
Up to 12 months
Adiponectin and leptin
Time Frame: Up to 12 months
Up to 12 months
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
Up to 12 months
Quality of life
Time Frame: Up to 12 months
Quality of Life is assessed by the EORTC QLQ-30 Questionnaire
Up to 12 months
Anxiety and depression
Time Frame: Up to 12 months
Anxiety and depression is assessed by the questionnaire: Hospital Anxiety and Depression Scale (HADS)
Up to 12 months
Fatigue
Time Frame: Up to 12 months
Fatigue is assessed by the questionnaire: Multidimensional Fatigue Inventory (MFI-20)
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Director: Gedske Daugaard, DMSc, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2013-1 75

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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