Short-term Testosterone replacement in testicular cancer survivors to treat overweight and improve cardiometabolic risk: a pilot study

Recruiting

Conditions: testicular cancer
10014701
10038597

Registration Number: NL-OMON50478

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

We will include patients with metastatic testicular cancer after chemotherapy,
at least 12 months after completion of last treatment and without evidence of
disease. Combination chemotherapy should have contained a platinum compound,
either cisplatin or carboplatin. In TC survivors, testosterone levels are
routinely measured in blood during follow-up once every two years. Patients are
eligible for screening if they are between 18 and 55 years of age, and have a
documented low or low-normal total testosterone level <=14 nmol/L, as measured
during any of the follow-up visits, irrespective of signs and symptoms of
androgen deficiency. Eligible for actual study participation and randomization
between Androgel and placebo will be: survivors of TC not using testosterone
supplements, having biochemical evidence of hypogonadism (defined as a serum
total testosterone
concentration <= 12 nmol/L (345 ng/dL) measured after an overnight fast between
8:00 and 10:00
AM), and being overweight (as defined by a BMI >= 25 and <35 kg/m2). Patients
should be able
to understand and abide to the study protocol and sign written informed
consent.

Exclusion Criteria

We will exclude: patients planning to father children within the next 12
months; patients already treated for hypogonadism, patients taking
corticosteroids or hormone replacement other than testosterone with
dose-adjusments within the last 3 months prior to randomization; patients
taking medication with any antiandrogenic effects (e.g. spironolactone);
patients with signs or history of hormone-dependent cancer (prostate or breast
cancer); patients with severe lower
urinary tract symptoms (as defined by International Prostate Symptom Score
>19); patients
with a history of coronary artery disease (angina pectoris, myocardial
infarction) or heart
failure; patients with hematocrit >50%; patients with untreated severe
obstructive sleep apnea;
patients with uncontrolled hypertension; patients with a BMI > 35 kg/m2;
patients with a history of
epilepsy; patients with debilitating psychiatric illness or inability to
understand the study protocol,
according to the opinion of the investigator.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the change in fat mass as measured by Dual-Energy X-ray<br /><br>Absorption (DEXA) scan after 20 weeks of Androgel compared to placebo.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are changes in fat mass between 20 and 40 weeks, and<br /><br>changes in abdominal visceral fat, BMI, adipocytokines, metabolic syndrome<br /><br>parameters, bone mass density, semen quality, sexual function, and quality of<br /><br>life between Androgel and placebotreated<br /><br>patients.</p><br>