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

NCT07439458 | Recruiting DMC

• 2 other identifiers: 2-PĒK-4/604/2025RSU/LSPA-PA-2024/1-0004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Exercise; Breast Cancer Cell Lines; Breast Cancer Survivors; Healthy Women; Myokine Response

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (1)

• 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.

Study Arms (2)

Breast Cancer Survivors

EXPERIMENTAL

Premenopausal breast cancer survivors (diagnosed with TNBC) 35 years old or older

Other: High intensity continuous exercise; Other: Moderate intensity continuous exercise

Healthy women

ACTIVE COMPARATOR

Healthy premenopausal women 35 years old or older

Other: High intensity continuous exercise; Other: Moderate intensity continuous exercise

Interventions

High intensity continuous exercise OTHER

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

Breast Cancer Survivors; Healthy women

Moderate intensity continuous exercise OTHER

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

Breast Cancer Survivors; Healthy women

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Riga Stradins University: lead

Study Sites (1)

Laboratory of Sports and Nutrition Research

Riga, Dzirciema Street 16, LV1007, Latvia

RECRUITING

Central Study Contacts

Dace Reihmane, PhD

CONTACT

+37126032249; Dace.Reihmane@rsu.lv

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Human Physiology and Biochemistry

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 27, 2026
• Study Start: April 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

LA (1)