Tumour Cell Response to Acute Aerobic Exercise in Breast Cancer Survivors: Modulatory Effects of Exercise Type and Intensity

NCT07439458 — Not applicable, Recruiting, 40 participants, Riga Stradins University

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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.

Registry	NCT07439458, acronym TCReX
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: none, basic science
Enrollment	40 (Estimated)
Sponsor	Riga Stradins University (Other)
Conditions	Acute Exercise, Breast Cancer Cell Lines, Breast Cancer Survivors, Healthy Women, Myokine Response
Interventions	High intensity continuous exercise, Moderate intensity continuous exercise (Other)
Dates	start 2024-04-01, primary completion 2026-03-31, completion 2026-09-30 (estimated), first posted 2026-02-27, last updated 2026-05-14
Locations	1 site in Latvia

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Breast Cancer Survivors	Experimental	Other: High intensity continuous exercise; Other: Moderate intensity continuous exercise	Premenopausal breast cancer survivors (diagnosed with TNBC) 35 years old or older
Healthy women	Active comparator	Other: High intensity continuous exercise; Other: Moderate intensity continuous exercise	Healthy premenopausal women 35 years old or older

High intensity continuous exercise (Other): 30 minutes of continuous exercise at 75% of VO2max, additionally 15 minutes of warm-up to reach specific workload.
Moderate intensity continuous exercise (Other): 30 minutes of continuous exercise at 45% of VO2max, additionally 15 minutes of warm-up to reach specific workload.

+Outcome measures

Primary outcomes

Inhibition of Breast Cancer Cell Proliferation [24 hours following cell exposure to serum collected at baseline (5 minutes pre-exercise) and immediately post-exercise (final minute of exercise).]: 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.
Changes in Serum Myokine Concentrations [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).]: 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.

Secondary outcomes

Correlation Between Body Composition and Myokine Response [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.]: 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.

+Eligibility

Sex: Female, ages: 35 Years to any, accepts healthy volunteers

Inclusion Criteria (intervention group):

* Reproductive age (premenopausal);
* 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));
* Timeframe of 3 to 9 months after completion of surgery, adjuvant chemotherapy, radiation therapy, and/or immunotherapy;
* Physician-certified (cardiologist) physical fitness for exercise testing, supported by echocardiography (ECHO).

Inclusion Criteria (control group):

* Reproductive age (premenopausal);
* No current or prior diagnosis of any type of cancer;
* Matched by age, body constitution, and physical fitness to the breast cancer participant group.

Exclusion Criteria:

* Pregnancy;
* Autoimmune diseases (e.g., thyroiditis, inflammatory bowel disease, atopic dermatitis, etc.);
* Endocrine disorders (e.g., metabolic syndrome, diabetes);
* Cardiovascular diseases;
* Diagnosis of any other type of oncological disease;
* Any condition for which physical activity is contraindicated (e.g., asthma, COPD, spinal disc herniation, severe iron deficiency anemia).

+Locations (1)

Facility	City	Country	Status
Laboratory of Sports and Nutrition Research	Riga, Dzirciema Street 16	Latvia	Recruiting

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