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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35+
SponsorRiga Stradins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

Pregnancy;

Autoimmune diseases (e.g., thyroiditis, inflammatory bowel disease, atopic dermatitis, etc.);

Endocrine disorders (e.g., metabolic syndrome, diabetes);

Cardiovascular diseases;

Trial design

Design model

Crossover

Treatments tested in this trial

  • High intensity continuous exercise

    Other intervention

    30 minutes of continuous exercise at 75% of VO2max, additionally 15 minutes of warm-up to reach specific workload.

  • Moderate intensity continuous exercise

    Other intervention

    30 minutes of continuous exercise at 45% of VO2max, additionally 15 minutes of warm-up to reach specific workload.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Breast Cancer SurvivorsExperimental treatment 2 interventions
Group B: Healthy womenActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours following cell exposure to serum collected at baseline (5 minutes pre-exercise) and immediately post-exercise (final minute of exercise).
2

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.

Time frame
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).

Secondary outcomes

1

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.

Time frame
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.

Other outcomes

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