Exercise in Testicular Germ Cell Cancer Survivors

NCT05063760 | Unknown

• 2 other identifiers: 2/0164/20SRDA19-0411
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Testicular Germ Cell Tumor

Keywords

TGCT; exercise intervention; Magnetic resonance spectroscopy; skeletal muscle; chemotherapy-induced metabolic toxicity

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

• change in quality of life for cancer patients

  measured twice before and after 6 month intervention

• change in muscle strength

  measured twice before and after 6 month intervention

• change in cognitive functions

  measured twice before and after 6 month intervention

Study Arms (2)

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

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

Interventions

aerobic-strength exercise intervention (6-months) BEHAVIORAL

6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week),

TGCT patients - exercise

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• TGCT survivors, with chemotherapy-induced metabolic toxicity, men, 25-55 years old, with the capacity to undergo training, signed written informed consent

You may not qualify if:

• serious / uncontrolled chronic diseases, non-compliance, other health issues as assessed by oncologists / investigators

Sponsors & Collaborators

• Slovak Academy of Sciences: lead
• Comenius University: collaborator

Study Sites (2)

National Cancer Institute

Bratislava, Please Select, 800 00, Slovakia

Location

Biomedical Research Center Slovak Academy of Sciences

Bratislava, Please Select, 84505, Slovakia

Location

MeSH Terms

Conditions

Testicular Germ Cell Tumor

Study Officials

• Barbara Ukropcova, MD, PhD, Prof

  Biomedical Research Center, Slovak Acad Sci

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: lab technicians and statistician are blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DSc

Model Details: controled trial with exercise intervention

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: October 1, 2021
• Study Start: January 15, 2020
• Primary Completion: December 1, 2023
• Study Completion: June 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)