Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT05063760
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2021-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise in Testicular Germ Cell Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563236', 'term': 'Testicular Germ Cell Tumor'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'lab technicians and statistician are blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'controled trial with exercise intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the glucose tolerance', 'timeFrame': 'parameter will be measured before and after 6 month intervention', 'description': 'change in glucose tolerance (as measured by oral glucose tolerance test)'}, {'measure': 'change in resting energy expenditiure and metabolic substrate preference', 'timeFrame': 'parameters will be measured twice before and after 6 month intervention', 'description': 'change in resting energy expenditure calculated by Weir equation from VO2 and metabolic substrate preference RQ VCO2/VO2 (as measured by indirect calorimetry)'}, {'measure': 'change anthropometric parameters of obesity', 'timeFrame': 'parameters will be measured twice before and after 6 month intervention', 'description': 'BMI (kg.m-2) , fat mass (% electric bioimpedance), lean body mass (% electric bioimpedance), visceral adiposity (%, elecgtric bioimpedance)'}, {'measure': 'change physical fitness', 'timeFrame': 'parameter will be measured twice before and after 6 month intervention', 'description': 'VO2max (mlO2 per kg BW min) as measured by bicycle spiroergometry'}], 'secondaryOutcomes': [{'measure': 'change in quality of life for cancer patients', 'timeFrame': 'measured twice before and after 6 month intervention', 'description': 'validated questionnaire'}, {'measure': 'change in muscle strength', 'timeFrame': 'measured twice before and after 6 month intervention', 'description': 'dynamometry'}, {'measure': 'change in cognitive functions', 'timeFrame': 'measured twice before and after 6 month intervention', 'description': 'standardised cognitive test Cogstate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TGCT', 'exercise intervention', 'Magnetic resonance spectroscopy', 'skeletal muscle', 'chemotherapy-induced metabolic toxicity'], 'conditions': ['Testicular Germ Cell Tumor']}, 'descriptionModule': {'briefSummary': "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.\n\nMechanisms 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.", 'detailedDescription': 'Aims:\n\n* 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).\n\n(iii) on metabolic characteristics of primary skeletal muscle cells;\n\n* 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;\n* 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;\n* To investigate the associations between intervention-induced shifts in circulating bioactive molecules and selected metabolic, anthropometric and motor parameters.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* TGCT survivors, with chemotherapy-induced metabolic toxicity, men, 25-55 years old, with the capacity to undergo training, signed written informed consent\n\nExclusion Criteria:\n\n* serious / uncontrolled chronic diseases, non-compliance, other health issues as assessed by oncologists / investigators'}, 'identificationModule': {'nctId': 'NCT05063760', 'acronym': 'ExCell', 'briefTitle': 'Exercise in Testicular Germ Cell Cancer Survivors', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Slovak Academy of Sciences'}, 'officialTitle': 'Exercise in Prevention & Treatment of Chemotherapy-related Late Toxicity in Testicular Germ Cell Cancer Survivors: the Role of Skeletal Muscle', 'orgStudyIdInfo': {'id': '2/0164/20'}, 'secondaryIdInfos': [{'id': 'SRDA19-0411', 'type': 'OTHER_GRANT', 'domain': 'Slovak Research and Development Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TGCT patients - exercise', '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', 'interventionNames': ['Behavioral: aerobic-strength exercise intervention (6-months)']}, {'type': 'NO_INTERVENTION', 'label': 'TGCT patients - nonexercising controls', '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'}], 'interventions': [{'name': 'aerobic-strength exercise intervention (6-months)', 'type': 'BEHAVIORAL', 'description': '6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week),', 'armGroupLabels': ['TGCT patients - exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '800 00', 'city': 'Bratislava', 'state': 'Please Select', 'country': 'Slovakia', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '84505', 'city': 'Bratislava', 'state': 'Please Select', 'country': 'Slovakia', 'facility': 'Biomedical Research Center Slovak Academy of Sciences', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], 'overallOfficials': [{'name': 'Barbara Ukropcova, MD, PhD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biomedical Research Center, Slovak Acad Sci'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'we will share IPD upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Slovak Academy of Sciences', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Comenius University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, DSc', 'investigatorFullName': 'Jozef Ukropec', 'investigatorAffiliation': 'Slovak Academy of Sciences'}}}}