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| ID | Type | Description | Link |
|---|---|---|---|
| RSU/LSPA-PA-2024/1-0004 | Other Grant/Funding Number | The project No. 5.2.1.1.i.0/2/24/I/CFLA/005, "RSU internal and RSU with LASE external consolidation" |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Survivors | Experimental | Premenopausal breast cancer survivors (diagnosed with TNBC) 35 years old or older |
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| Healthy women | Active Comparator | Healthy premenopausal women 35 years old or older |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity continuous exercise | Other | 30 minutes of continuous exercise at 75% of VO2max, additionally 15 minutes of warm-up to reach specific workload. |
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| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of Breast Cancer Cell Proliferation | The inhibitory effect of exercise-conditioned serum (ECS) on the proliferation of breast cancer cell lines (MDA-MB-231, HCC1937, HCC1143, and SK-BR-3). 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. | 24 hours following cell exposure to serum collected at baseline (5 minutes pre-exercise) and immediately post-exercise (final minute of exercise). |
| Changes in Serum Myokine Concentrations | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Body Composition and Myokine Response | 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. | 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. |
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Inclusion Criteria (intervention group):
Inclusion Criteria (control group):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dace Reihmane, PhD | Contact | +37126032249 | Dace.Reihmane@rsu.lv |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Sports and Nutrition Research | Recruiting | Riga | Dzirciema Street 16 | LV1007 | Latvia |
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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.
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.
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| Moderate intensity continuous exercise | Other | 30 minutes of continuous exercise at 45% of VO2max, additionally 15 minutes of warm-up to reach specific workload. |
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