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Exercise in Testicular Germ Cell Cancer Survivors (ExCell)

S

Slovak Academy of Sciences

Status

Active, not recruiting

Conditions

Testicular Germ Cell Tumor

Treatments

Behavioral: aerobic-strength exercise intervention (6-months)

Study type

Interventional

Funder types

Other

Identifiers

NCT05063760
SRDA19-0411 (Other Grant/Funding Number)
2/0164/20

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Male

Ages

25 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

TGCT patients - exercise
Experimental group
Description:
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
Treatment:
Behavioral: aerobic-strength exercise intervention (6-months)
TGCT patients - nonexercising controls
No Intervention group
Description:
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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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