Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Overweight

Testicular Neoplasms

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Antineoplastic Agents

All Drugs and Chemicals

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Androgens

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Patients will be randomized to treatment with transdermal testosterone gel (Androgel) once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

Patients will be randomized to treatment with placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

Androgel (Testosterone gel)

Patients will be randomized to treatment with transdermal placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

Placebo gel

Janine Nuver, MD, PhD

To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome. A randomized double-blind placebo controlled intervention study, followed by an open-label treatment phase. Results of this pilot study will be used to design a multicenter randomized controlled study in a large group of TC survivors

Rationale: Testicular cancer (TC) survivors have an increased risk of hypogonadism (decreased testosterone and/or increased luteinizing hormone levels) and cardiovascular disease (CVD). Metabolic syndrome develops early after chemotherapy in 20-30% of long-term TC survivors and is associated with an increased risk of atherosclerotic disease in the general population. TC survivors who develop the metabolic syndrome have a higher body mass index (BMI) pretreatment, a larger BMI increase during follow-up, and lower total testosterone levels than patients without the metabolic syndrome. Testosterone replacement therapy as a short-term intervention during a limited time period may be an important strategy to reduce body weight and fat mass, restore cardiometabolic balance, and decrease the prevalence of the metabolic syndrome in TC survivors.

Objective: to assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome.

Study design: randomized double-blind placebo controlled intervention study, followed by an open-label treatment phase. Results of this pilot study will be used to design a multicenter randomized controlled study in a large group of TC survivors

Study population: 40 TC patients, aged 18-55 years, at least 12 months after completion of curative treatment with unilateral orchidectomy and platinum-based chemotherapy, and having a fasting total testosterone level ≤12 nmol/l and a BMI ≥25 kg/m2.

Intervention: Patients will be randomized to treatment with transdermal testosterone gel (Androgel) or placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants. The treatment dose will be 50 mg daily, adjusted to 25 mg in case of increased testosterone concentrations (average of 2 measurements \>25 nmol/L) or signs of overdosing. Patients will be stratified according to testosterone level (8-12 nmol/L versus \<8 nmol/L) and BMI (25-30 kg/m2 versus 30-35 kg/m2).

Main study parameters/endpoints: Primary endpoint is the change in fat mass as measured by Dual-Energy X-ray Absorption (DEXA) scan after 20 weeks of Androgel compared to placebo. Secondary endpoints are changes in fat mass between 20 and 40 weeks, and changes in abdominal visceral fat, BMI, adipocytokines, metabolic syndrome parameters, bone mass density, semen quality, sexual function, and quality of life between Androgel and placebo-treated patients.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will provide an answer to the question whether testosterone replacement therapy as a short-term intervention has significant effects on obesity and fat metabolism and may, thus, reduce the prevalence of the metabolic syndrome in this population of young men with excellent long-term cancer-related prognosis, but an increased CVD risk. At various time points during the intervention, patients will be subjected to history taking and physical examination. Furthermore, blood will be drawn to: measure hormone levels, adipocytokines, lipids, glucose, insulin, and bone markers; to extract DNA for determination of gene polymorphisms; and to measure hematocrit and PSA as safety parameters. Semen analysis and a full body DEXA scan will be performed at 0, 20 and 40 weeks only. Patients will be asked to fill out questionnaires regarding quality of life, sexual health, and androgen deficiency symptoms at various time points during the intervention.

Short-term Testosterone Replacement in Testicular Cancer Survivors

Short-term Testosterone Replacement in Testicular Cancer Survivors to Treat Overweight and Improve Cardiometabolic Risk: A Pilot Study

To assess the effects of 20 weeks of treatment with testosterone gel on fat mass as measured using full body dual X-ray absorptiometry (DEXA scan).

To assess the effects of 20 and 40 weeks of treatment with testosterone gel on obesity

To assess the effects of 20 and 40 weeks of treatment with testosterone gel on signs and symptoms of hypogonadism

University Medical Center Groningen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Short-term Testosterone Replacement in Testicular Cancer Survivors	NCT03339635	Testicular Canc...	Androgel (Testo... Placebo gel	18 Years - 55 Years	University Medical Center Groningen
Short-term Testosterone Replacement in Testicular Cancer Survivors	NCT03339635	Testicular Canc...	Androgel (Testo... Placebo gel	18 Years - 55 Years	University Medical Center Groningen

Spots Global Cancer Trial Database for androgel (testosterone gel)