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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Women; Acute Exercise; Breast Cancer Survivors; Breast Cancer Cell Lines; Myokine Response
• Intervention / Treatment: Other: High intensity continuous exercise; Other: Moderate intensity continuous exercise

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dace Reihmane, PhD; Phone Number: +37126032249; Email: Dace.Reihmane@rsu.lv

Study Locations

• Latvia
  • Dzirciema Street 16
    • Riga, Dzirciema Street 16, Latvia, LV1007
      • Recruiting
      • Laboratory of Sports and Nutrition Research
      • Contact: Dace Reihmane, PhD; Phone Number: +37126032249; Email: Dace.Reihmane@rsu.lv
      • Contact: Email: lsnr@rsu.lv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breast Cancer Survivors; Premenopausal breast cancer survivors (diagnosed with TNBC) 35 years old or older	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.
Active Comparator: Healthy women; Healthy premenopausal women 35 years old or older	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Riga Stradins University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): March 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2-PĒK-4/604/2025; 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")

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No