Testicular Germ Cell TumorExCellNCT05063760
Exercise in Testicular Germ Cell Cancer Survivors
A study testing aerobic-strength exercise intervention (6-months) in people with Testicular Germ Cell Tumor, run by Slovak Academy of Sciences at 2 sites in Slovakia.
Trial summary
Regular exercise is effective in prevention \& treatment of chronic diseases. Exercise can reduce late toxicity of chemotherapy, commonly found in cancer survivors, which is yet to be translated into clinical practice. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men only
- Conditions the study is for
- Testicular Germ Cell Tumor
- What is being tested?
- aerobic-strength exercise intervention (6-months)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSlovakia
- Study dates
- 15 Jan 2020to 30 Jun 2024
- Phase
- Interventional
- 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 25 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- TGCT survivors, with chemotherapy-induced metabolic toxicity, men, 25-55 years old, with the capacity to undergo training, signed written informed consent
Who cannot join
- serious / uncontrolled chronic diseases, non-compliance, other health issues as assessed by oncologists / investigators
Trial locations and contacts
2 sites in 1 country.
Slovakia2 sites
National Cancer Institute
Bratislava, Please Select, 800 00
Biomedical Research Center Slovak Academy of Sciences
Bratislava, Please Select, 84505
About this study
Official title: Exercise in Prevention & Treatment of Chemotherapy-related Late Toxicity in Testicular Germ Cell Cancer Survivors: the Role of Skeletal Muscle
Regular exercise is effective in prevention \& treatment of chronic diseases. Exercise can reduce late toxicity of chemotherapy, commonly found in cancer survivors, which is yet to be translated into clinical practice.
Mechanisms of exercise benefits in oncologic patients are far from being elucidated, and include increase in muscle mass, reduction of fat mass, systemic inflammation and cardiometabolic risk. Synchronization of exercise adaptive response is, to an extent, mediated by bioactive molecules released from muscle, with anti-inflammatory \& tumor-suppressing properties. Muscle satellite cells are a source of regeneration, muscle structural integrity \& functional capacity. Phenotypes of muscle cells, such as secretory profile, lipid \& glucose metabolism, mirror clinical phenotypes of the donor. Importantly, muscle cells' metabolism in vitro can be modulated by 8-12 week training in vivo. Epigenetic mechanisms regulating muscle \& systemic metabolism in cancer survivors are not yet understood.
Read the detailed description
Aims:
- To assess the impact of 6-month supervised, individualized aerobic-strength exercise training intervention in cancer survivors with chemotherapy-induced late toxicity . (i) on the whole-body energy and glucose metabolism, anthropometric parameters, physical fitness \& activity profile, motor functions and quality of life in testicular germ cell cancer (TGCC) survivors, more than 3 years after cisplatin-based chemotherapy; with the 2-year follow up; . (ii) on skeletal muscle mass, morphology as well as functional and metabolic state detected in vivo (31P-MR spectroscopy). (iii) on metabolic characteristics of primary skeletal muscle cells;
- To determine the impact of exercise intervention on circulating bioactive molecules (exerkines), putative mediators of exercise health benefits as well as on levels of circulating inflammatory cytokines, which likely contribute to the pathogenesis of chemotherapy-induced late toxicity;
- To evaluate the role of (a) selected exercise-regulated bioactive molecules, (b) exercise-mimicking treatment (by electric pulse stimulation) and (c) cisplatin treatment on metabolism and mitochondrial function of differentiated human muscle cells in culture;
- To investigate the associations between intervention-induced shifts in circulating bioactive molecules and selected metabolic, anthropometric and motor parameters.
The generated results will enable us (i) to gain a better insight into pathomechanisms of muscle-associated chemotherapy-induced late toxicity and the role of skeletal muscle \& systemic mediators in the exercise-induced health benefits in TGCC survivors; and (ii) to validate the effectiveness of the individually-tailored exercise intervention in reducing chemotherapy-related toxicity in patients with TGCC, with the aim to transfer this knowledge into clinical practice.
- Conditions
- Testicular Germ Cell Tumor
- Being tested
- aerobic-strength exercise intervention (6-months)
- Keywords
- TGCT, exercise intervention, Magnetic resonance spectroscopy, skeletal muscle, chemotherapy-induced metabolic toxicity
- Medical subject headings
- Testicular Germ Cell Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic-strength exercise intervention (6-months)Behavioural
6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week),
| Study group | Role | What they receive |
|---|---|---|
| TGCT patients - exercise | Experimental | TGCT survivors, men, 25-55 yrs old, 3 and more years after successful treatment of TGCT, with the capacity to undergo aerobic-strength intervention assessed by cardiologist Receives: Behavioral: aerobic-strength exercise intervention (6-months) |
| TGCT patients - nonexercising controls | No intervention | TGCT survivors, men, 25-55 yrs old, 3 and more years after successful treatment of TGCT, with the capacity to undergo aerobic-strength intervention assessed by cardiologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the glucose tolerance
change in glucose tolerance (as measured by oral glucose tolerance test)
Measured: parameter will be measured before and after 6 month intervention
change in resting energy expenditiure and metabolic substrate preference
change in resting energy expenditure calculated by Weir equation from VO2 and metabolic substrate preference RQ VCO2/VO2 (as measured by indirect calorimetry)
Measured: parameters will be measured twice before and after 6 month intervention
change anthropometric parameters of obesity
BMI (kg.m-2) , fat mass (% electric bioimpedance), lean body mass (% electric bioimpedance), visceral adiposity (%, elecgtric bioimpedance)
Measured: parameters will be measured twice before and after 6 month intervention
change physical fitness
VO2max (mlO2 per kg BW min) as measured by bicycle spiroergometry
Measured: parameter will be measured twice before and after 6 month intervention
Secondary outcomes (3)
change in quality of life for cancer patients
validated questionnaire
Measured: measured twice before and after 6 month intervention
change in muscle strength
dynamometry
Measured: measured twice before and after 6 month intervention
change in cognitive functions
standardised cognitive test Cogstate
Measured: measured twice before and after 6 month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start15 Jan 2020
- Primary completion1 Dec 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular Germ Cell TumorStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- controled trial with exercise intervention
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Comenius University
- Responsible party
- Principal investigator, Jozef Ukropec, Slovak Academy of Sciences
- Investigators
- Barbara Ukropcova, MD, PhD, Prof, Principal investigator, Biomedical Research Center, Slovak Acad Sci
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063760
- Sponsor's protocol ID
- 2/0164/20
- Other IDs
- SRDA19-0411
- Acronym
- ExCell
- Status last verified
- Dec 2023
- First submitted
- 18 Mar 2021
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will share IPD upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Prevention & Treatment of Chemotherapy-related Late Toxicity in Testicular Germ Cell Cancer Survivors: the Role of Skeletal Muscle
- ClinicalTrials.gov ID
- NCT05063760
- Acronym / sponsor ID
- ExCell / 2/0164/20
- Conditions
- Testicular Germ Cell Tumor
- Keywords
- TGCT, exercise intervention, Magnetic resonance spectroscopy, skeletal muscle, chemotherapy-induced metabolic toxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Collaborators
- Comenius University
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 1 Oct 2021 (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.
Regular exercise is effective in prevention \& treatment of chronic diseases. Exercise can reduce late toxicity of chemotherapy, commonly found in cancer survivors, which is yet to be translated into clinical practice.
Mechanisms of exercise benefits in oncologic patients are far from being elucidated, and include increase in muscle mass, reduction of fat mass, systemic inflammation and cardiometabolic risk. Synchronization of exercise adaptive response is, to an extent, mediated by bioactive molecules released from muscle, with anti-inflammatory \& tumor-suppressing properties. Muscle satellite cells are a source of regeneration, muscle structural integrity \& functional capacity. Phenotypes of muscle cells, such as secretory profile, lipid \& glucose metabolism, mirror clinical phenotypes of the donor. Importantly, muscle cells' metabolism in vitro can be modulated by 8-12 week training in vivo. Epigenetic mechanisms regulating muscle \& systemic metabolism in cancer survivors are not yet understood.
Detailed description
Aims:
- To assess the impact of 6-month supervised, individualized aerobic-strength exercise training intervention in cancer survivors with chemotherapy-induced late toxicity . (i) on the whole-body energy and glucose metabolism, anthropometric parameters, physical fitness \& activity profile, motor functions and quality of life in testicular germ cell cancer (TGCC) survivors, more than 3 years after cisplatin-based chemotherapy; with the 2-year follow up; . (ii) on skeletal muscle mass, morphology as well as functional and metabolic state detected in vivo (31P-MR spectroscopy). (iii) on metabolic characteristics of primary skeletal muscle cells;
- To determine the impact of exercise intervention on circulating bioactive molecules (exerkines), putative mediators of exercise health benefits as well as on levels of circulating inflammatory cytokines, which likely contribute to the pathogenesis of chemotherapy-induced late toxicity;
- To evaluate the role of (a) selected exercise-regulated bioactive molecules, (b) exercise-mimicking treatment (by electric pulse stimulation) and (c) cisplatin treatment on metabolism and mitochondrial function of differentiated human muscle cells in culture;
- To investigate the associations between intervention-induced shifts in circulating bioactive molecules and selected metabolic, anthropometric and motor parameters.
The generated results will enable us (i) to gain a better insight into pathomechanisms of muscle-associated chemotherapy-induced late toxicity and the role of skeletal muscle \& systemic mediators in the exercise-induced health benefits in TGCC survivors; and (ii) to validate the effectiveness of the individually-tailored exercise intervention in reducing chemotherapy-related toxicity in patients with TGCC, with the aim to transfer this knowledge into clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- controled trial with exercise intervention
| Arm | Type | Receives |
|---|---|---|
| TGCT patients - exercise | Experimental | Behavioral: aerobic-strength exercise intervention (6-months)TGCT survivors, men, 25-55 yrs old, 3 and more years after successful treatment of TGCT, with the capacity to undergo aerobic-strength intervention assessed by cardiologist |
| TGCT patients - nonexercising controls | No intervention | –TGCT survivors, men, 25-55 yrs old, 3 and more years after successful treatment of TGCT, with the capacity to undergo aerobic-strength intervention assessed by cardiologist |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- TGCT survivors, with chemotherapy-induced metabolic toxicity, men, 25-55 years old, with the capacity to undergo training, signed written informed consent
Key exclusion criteria (1 listed)
- serious / uncontrolled chronic diseases, non-compliance, other health issues as assessed by oncologists / investigators
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 |
|---|---|---|
| aerobic-strength exercise intervention (6-months)6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week), | Behavioural | TGCT patients - exercise |
Primary outcome
change in the glucose tolerance
Time frame: parameter will be measured before and after 6 month intervention
change in glucose tolerance (as measured by oral glucose tolerance test)
change in resting energy expenditiure and metabolic substrate preference
Time frame: parameters will be measured twice before and after 6 month intervention
change in resting energy expenditure calculated by Weir equation from VO2 and metabolic substrate preference RQ VCO2/VO2 (as measured by indirect calorimetry)
change anthropometric parameters of obesity
Time frame: parameters will be measured twice before and after 6 month intervention
BMI (kg.m-2) , fat mass (% electric bioimpedance), lean body mass (% electric bioimpedance), visceral adiposity (%, elecgtric bioimpedance)
change physical fitness
Time frame: parameter will be measured twice before and after 6 month intervention
VO2max (mlO2 per kg BW min) as measured by bicycle spiroergometry
3 secondary outcomes
change in quality of life for cancer patients
Time frame: measured twice before and after 6 month intervention
change in muscle strength
Time frame: measured twice before and after 6 month intervention
change in cognitive functions
Time frame: measured twice before and after 6 month intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No. we will share IPD upon reasonable request
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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.
Barbara Ukropcova, MD, PhD, Prof principal investigator
Biomedical Research Center, Slovak Acad Sci
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic-strength exercise intervention (6-months) in people with Testicular Germ Cell Tumor, run by Slovak Academy of Sciences at 2 sites in Slovakia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovakia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
change in the glucose tolerance (time frame: parameter will be measured before and after 6 month intervention). The study lists 4 primary outcomes in all. 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 5 Dec 2023.