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Acute ExerciseTCReXNCT07439458

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

A study testing High intensity continuous exercise and Moderate intensity continuous exercise in people with Acute Exercise and Breast Cancer Cell Lines, run by Riga Stradins University at 1 site in Latvia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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'… Read more about this study

Who is it for?
Ages 35 years and older, women onlyHealthy volunteers can take part
What is being tested?
High intensity continuous exercise and Moderate intensity continuous exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteLatvia
Study dates
1 Apr 2024to 30 Sep 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dace Reihmane, PhD contact

+37126032249

Dace.Reihmane@rsu.lv

Latvia1 site, 1 recruiting
  • Laboratory of Sports and Nutrition Research

    Riga, Dzirciema Street 16, LV1007

    Dace Reihmane, PhD, +37126032249, Dace.Reihmane@rsu.lv

    lsnr@rsu.lv

    Recruiting

Other trials in Latvia

About this study

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.

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.

Being tested
High intensity continuous exercise, Moderate intensity continuous exercise

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity continuous exerciseOther

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

  • Moderate intensity continuous exerciseOther

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

Study groups in NCT07439458
Study groupRoleWhat they receive
Breast Cancer SurvivorsExperimentalPremenopausal breast cancer survivors (diagnosed with TNBC) 35 years old or older
Receives: Other: High intensity continuous exercise; Other: Moderate intensity continuous exercise
Healthy womenActive comparatorHealthy premenopausal women 35 years old or older
Receives: Other: High intensity continuous exercise; Other: Moderate intensity continuous exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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)
  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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Apr 2024
  3. Primary completion31 Mar 2026
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07439458
Sponsor's protocol ID
2-PĒK-4/604/2025
Other IDs
RSU/LSPA-PA-2024/1-0004
Acronym
TCReX
Status last verified
May 2026
First submitted
29 Jan 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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