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Recruiting NCT07439458

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

No phase Interventional Acute Exercise Breast Cancer Cell Lines Breast Cancer Survivors Healthy Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High intensity continuous exercise, Moderate intensity continuous exercise.
Who it may be relevant to
Registry conditions: Acute Exercise, Breast Cancer Cell Lines, Breast Cancer Survivors, Healthy Women. Basic parameters: from 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Latvia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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.

Overview

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.

Interventions

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

Primary outcome measures

  • Inhibition of Breast Cancer Cell Proliferation [Time frame: 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 [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 outcome measures (1)
  • Correlation Between Body Composition and Myokine Response [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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

Latvia · 1 center
  • Laboratory of Sports and Nutrition Research — Riga

Identifiers

NCT: NCT07439458 · 2-PĒK-4/604/2025 · RSU/LSPA-PA-2024/1-0004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗