Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2020-01-15
2024-06-30
Brief Summary
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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
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* 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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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TGCT patients - exercise
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
aerobic-strength exercise intervention (6-months)
6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week),
TGCT patients - nonexercising controls
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
No interventions assigned to this group
Interventions
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aerobic-strength exercise intervention (6-months)
6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week),
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
55 Years
MALE
No
Sponsors
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Comenius University
OTHER
Slovak Academy of Sciences
OTHER_GOV
Responsible Party
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Jozef Ukropec
PhD, DSc
Principal Investigators
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Barbara Ukropcova, MD, PhD, Prof
Role: PRINCIPAL_INVESTIGATOR
Biomedical Research Center, Slovak Acad Sci
Locations
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National Cancer Institute
Bratislava, Please Select, Slovakia
Biomedical Research Center Slovak Academy of Sciences
Bratislava, Please Select, Slovakia
Countries
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Other Identifiers
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SRDA19-0411
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2/0164/20
Identifier Type: -
Identifier Source: org_study_id