Testicular CancerPhase 2NCT03339635
Short-term Testosterone Replacement in Testicular Cancer Survivors
A Phase 2 study testing Androgel (Testosterone gel) in people with Testicular Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Androgel (Testosterone gel)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Dec 2018to 26 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- patients with metastatic testicular cancer after unilateral orchidectomy and 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
- 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.
Who cannot join
- patients with a history of extragonadal testicular cancer
- patients planning to father children within the next 12 months
- patients taking corticosteroids or hormone replacement other than testosterone within 3 months of 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Testosterone Replacement in Testicular Cancer Survivors to Treat Overweight and Improve Cardiometabolic Risk: A Pilot Study
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
Read the detailed description
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.
- Conditions
- Testicular Cancer
- Being tested
- Androgel (Testosterone gel), Placebo gel
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgel (Testosterone gel)Drug
Also called Androgel
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.
Placebo gelDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone gel | Experimental | 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. Receives: Drug: Androgel (Testosterone gel) |
| Placebo gel | Placebo comparator | 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. Receives: Drug: Androgel (Testosterone gel); Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent change in fat mass as measured using using full body dual X-ray absorptiometry
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).
Measured: 20 weeks of treatment
Secondary outcomes (2)
Effect of treatment with testosterone gel
To assess the effects of 20 and 40 weeks of treatment with testosterone gel on obesity
Measured: 20 and 40 weeks of treatment
Effect of treatment with testosterone gel
To assess the effects of 20 and 40 weeks of treatment with testosterone gel on signs and symptoms of hypogonadism
Measured: 20 and 40 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start21 Dec 2018
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janine Nuver, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339635
- Sponsor's protocol ID
- 201600107
- Status last verified
- Jul 2024
- First submitted
- 10 May 2016
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Testosterone Replacement in Testicular Cancer Survivors to Treat Overweight and Improve Cardiometabolic Risk: A Pilot Study
- ClinicalTrials.gov ID
- NCT03339635
- Acronym / sponsor ID
- 201600107
- Conditions
- Testicular Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone gel | Experimental | Drug: Androgel (Testosterone gel)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. |
| Placebo gel | Placebo comparator | Drug: Androgel (Testosterone gel), Drug: Placebo gelPatients will be randomized to treatment with placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- patients with metastatic testicular cancer after unilateral orchidectomy and 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
- 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).
Key exclusion criteria (13 listed)
- patients with a history of extragonadal testicular cancer
- patients planning to father children within the next 12 months
- patients taking corticosteroids or hormone replacement other than testosterone within 3 months of randomization
- patients taking medication with any antiandrogenic effects (e.g. spironolactone)
- patients with signs or history of hormone-dependent cancer (prostate or breast cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgel (Testosterone gel)Also: AndrogelPatients 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. | Drug | Placebo gel, Testosterone gel |
| Placebo gelAlso: PlaceboPatients 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. | Drug | Placebo gel |
Primary outcome
percent change in fat mass as measured using using full body dual X-ray absorptiometry
Time frame: 20 weeks of treatment
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).
2 secondary outcomes
Effect of treatment with testosterone gel
Time frame: 20 and 40 weeks of treatment
Effect of treatment with testosterone gel
Time frame: 20 and 40 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janine Nuver, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgel (Testosterone gel) in people with Testicular Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent change in fat mass as measured using using full body dual X-ray absorptiometry (time frame: 20 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.