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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05063760
Other study ID # 2/0164/20
Secondary ID SRDA19-0411
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 15, 2020
Est. completion date June 30, 2024

Study information

Verified date December 2023
Source Slovak Academy of Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date June 30, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 25 Years to 55 Years
Eligibility Inclusion Criteria: - TGCT survivors, with chemotherapy-induced metabolic toxicity, men, 25-55 years old, with the capacity to undergo training, signed written informed consent Exclusion Criteria: - serious / uncontrolled chronic diseases, non-compliance, other health issues as assessed by oncologists / investigators

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
aerobic-strength exercise intervention (6-months)
6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week),

Locations

Country Name City State
Slovakia Biomedical Research Center Slovak Academy of Sciences Bratislava Please Select
Slovakia National Cancer Institute Bratislava Please Select

Sponsors (2)

Lead Sponsor Collaborator
Slovak Academy of Sciences Comenius University

Country where clinical trial is conducted

Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in the glucose tolerance change in glucose tolerance (as measured by oral glucose tolerance test) parameter will be measured before and after 6 month intervention
Primary 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) parameters will be measured twice before and after 6 month intervention
Primary change anthropometric parameters of obesity BMI (kg.m-2) , fat mass (% electric bioimpedance), lean body mass (% electric bioimpedance), visceral adiposity (%, elecgtric bioimpedance) parameters will be measured twice before and after 6 month intervention
Primary change physical fitness VO2max (mlO2 per kg BW min) as measured by bicycle spiroergometry parameter will be measured twice before and after 6 month intervention
Secondary change in quality of life for cancer patients validated questionnaire measured twice before and after 6 month intervention
Secondary change in muscle strength dynamometry measured twice before and after 6 month intervention
Secondary change in cognitive functions standardised cognitive test Cogstate measured twice before and after 6 month intervention
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