An interventional study of aerobic-strength exercise intervention (6-months) in Testicular Germ Cell Tumor, sponsored by Slovak Academy of Sciences. Active, not recruiting at 2 sites in Slovakia. Open to male participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Slovak Academy of Sciences · Not applicable, Interventional, and Supportive care
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.
Aims:
(iii) on metabolic characteristics of primary skeletal muscle cells;
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.
85 studies on the registry are indexed under Testicular Germ Cell Tumor; 10 are open to participants now.
This study's planned enrollment of 60 is above the median of 46 across 54 interventional studies indexed under Testicular Germ Cell Tumor.
Browse Testicular Germ Cell Tumor studies →Slovak Academy of Sciences is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week),
change in the glucose tolerance
change in glucose tolerance (as measured by oral glucose tolerance test)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: parameter will be measured twice before and after 6 month intervention
change in quality of life for cancer patients
validated questionnaire
Time frame: measured twice before and after 6 month intervention
change in muscle strength
dynamometry
Time frame: measured twice before and after 6 month intervention
change in cognitive functions
standardised cognitive test Cogstate
Time frame: measured twice before and after 6 month intervention
Plan to share: No — we will share IPD upon reasonable request
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Dec 2023, 46 months.
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This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Slovak Academy of Sciences