Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:31 AM
Study NCT ID:
NCT07439458
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumour Cell Response to Acute Aerobic Exercise in Breast Cancer Survivors: Modulatory Effects of Exercise Type and Intensity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inhibition of Breast Cancer Cell Proliferation', 'timeFrame': '24 hours following cell exposure to serum collected at baseline (5 minutes pre-exercise) and immediately post-exercise (final minute of exercise).', 'description': 'The inhibitory effect of exercise-conditioned serum (ECS) on the proliferation of breast cancer cell lines (MCF-7, SK-BR-3, and Hs578BT). Proliferation is measured as the percentage of viable cells after 24 hours of exposure to serum collected during exercise compared to baseline (pre-exercise) serum samples, using LIVE/DEAD fluorescence microscopy and FM CellHealth assays.'}, {'measure': 'Changes in Serum Myokine Concentrations', 'timeFrame': 'Blood samples were collected 5 minutes pre-exercise (baseline), 15, 30, and 45 minutes (final minute of exercise) at Day 8 (Visit 2) and Day 15 (Visit 3).', 'description': 'Measurement of serum levels of six specific myokines (BDNF, SPARC, Oncostatin M, IL-6, FGF-21, and Decorin) known to exhibit anticarcinogenic effects. Concentrations will be determined using ELISA or xMAP technology.'}], 'secondaryOutcomes': [{'measure': 'Correlation Between Body Composition and Myokine Response', 'timeFrame': 'Day 1 (Visit 1): Baseline measurements (measured once during the initial screening). All measures were performed in the morning, from 8 a.m. to 12 p.m., after overnight fasting.', 'description': 'Assessment of how body composition parameters - specifically fat mass, lean soft tissue mass, visceral fat, measured via Dual-Energy X-ray Absorptiometry (DEXA) - correlate with the magnitude of exercise-induced myokine fluctuations.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Exercise', 'Breast Cancer Cell Lines', 'Breast Cancer Survivors', 'Healthy Women', 'Myokine Response']}, 'descriptionModule': {'briefSummary': "Cancer has emerged as a prominent cause of mortality in the 21st century, with breast cancer (BC) being the most diagnosed malignancy. Multidisciplinary cancer management has improved survival chances, but side effects and long-term consequences of treatments have significant implications for cancer survivors' health-related quality of life. Exercise is increasingly considered and used in cancer treatment and follow-up. However, studies demonstrating the biological mechanisms underlying the anticarcinogenic effects (ACE) of exercise are insufficient to justify the most appropriate physical activity for different clinical scenarios. Achieving scientific excellence in understanding the ACE of exercise in cancer management is critical to optimize treatment and enhance patients' quality of life."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (intervention group):\n\n* Reproductive age (premenopausal);\n* Diagnosis of Stage II-III Triple-Negative Breast Cancer (TNBC) (negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2));\n* Timeframe of 3 to 9 months after completion of surgery, adjuvant chemotherapy, radiation therapy, and/or immunotherapy;\n* Physician-certified (cardiologist) physical fitness for exercise testing, supported by echocardiography (ECHO).\n\nInclusion Criteria (control group):\n\n* Reproductive age (premenopausal);\n* No current or prior diagnosis of any type of cancer;\n* Matched by age, body constitution, and physical fitness to the breast cancer participant group.\n\nExclusion Criteria:\n\n* Pregnancy;\n* Autoimmune diseases (e.g., thyroiditis, inflammatory bowel disease, atopic dermatitis, etc.);\n* Endocrine disorders (e.g., metabolic syndrome, diabetes);\n* Cardiovascular diseases;\n* Diagnosis of any other type of oncological disease;\n* Any condition for which physical activity is contraindicated (e.g., asthma, COPD, spinal disc herniation, severe iron deficiency anemia).'}, 'identificationModule': {'nctId': 'NCT07439458', 'acronym': 'TCReX', 'briefTitle': 'Tumour Cell Response to Acute Aerobic Exercise in Breast Cancer Survivors: Modulatory Effects of Exercise Type and Intensity', 'organization': {'class': 'OTHER', 'fullName': 'Riga Stradins University'}, 'officialTitle': 'Tumour Cell Response to Acute Aerobic Exercise in Breast Cancer Survivors: Modulatory Effects of Exercise Type and Intensity (TCReX) No: RSU/LSPA-PA-2024/1-0004 is Financed by the Investment of the European Union Recovery and Resilience Facility and the State Budget Within the Project "RSU Internal and RSU With LASE External Consolidation" No. 5.2.1.1.i.0/2/24/I/CFLA/005.', 'orgStudyIdInfo': {'id': '2-PĒK-4/604/2025'}, 'secondaryIdInfos': [{'id': 'RSU/LSPA-PA-2024/1-0004', 'type': 'OTHER_GRANT', 'domain': 'The project No. 5.2.1.1.i.0/2/24/I/CFLA/005, "RSU internal and RSU with LASE external consolidation"'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breast Cancer Survivors', 'description': 'Premenopausal breast cancer survivors (diagnosed with TNBC) 35 years old or older', 'interventionNames': ['Other: High intensity continuous exercise', 'Other: Moderate intensity continuous exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy women', 'description': 'Healthy premenopausal women 35 years old or older', 'interventionNames': ['Other: High intensity continuous exercise', 'Other: Moderate intensity continuous exercise']}], 'interventions': [{'name': 'High intensity continuous exercise', 'type': 'OTHER', 'description': '30 minutes of continuous exercise at 75% of VO2max, additionally 15 minutes of warm-up to reach specific workload.', 'armGroupLabels': ['Breast Cancer Survivors', 'Healthy women']}, {'name': 'Moderate intensity continuous exercise', 'type': 'OTHER', 'description': '30 minutes of continuous exercise at 45% of VO2max, additionally 15 minutes of warm-up to reach specific workload.', 'armGroupLabels': ['Breast Cancer Survivors', 'Healthy women']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LV1007', 'city': 'Riga', 'state': 'Dzirciema Street 16', 'status': 'RECRUITING', 'country': 'Latvia', 'contacts': [{'name': 'Dace Reihmane, PhD', 'role': 'CONTACT', 'email': 'Dace.Reihmane@rsu.lv', 'phone': '+37126032249'}, {'role': 'CONTACT', 'email': 'lsnr@rsu.lv'}], 'facility': 'Laboratory of Sports and Nutrition Research', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}], 'centralContacts': [{'name': 'Dace Reihmane, PhD', 'role': 'CONTACT', 'email': 'Dace.Reihmane@rsu.lv', 'phone': '+37126032249'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Individual participant data (IPD) will be available beginning 6 months after the publication of the final study results. The data will remain accessible for a period of 5 years following the initial release.', 'ipdSharing': 'YES', 'accessCriteria': 'De-identified individual participant data that underlie the results reported in this study will be shared with researchers and interested parties who provide a methodologically sound proposal via RSU dataverse. To gain access, data requestors must submit a formal request to the Principal Investigator (Dace Reihmane, dace.reihmane@rsu.lv) and sign a data access agreement. Requests will be reviewed by the study team and Riga Stradiņš University (RSU) Data Security and Management Unit to ensure compliance with GDPR and FAIR principles.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riga Stradins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Human Physiology and Biochemistry', 'investigatorFullName': 'Dace Reihmane', 'investigatorAffiliation': 'Riga Stradins University'}}}}