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.
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
- Conditions the study is for
- Acute Exercise, Breast Cancer Cell Lines, Breast Cancer Survivors
- 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
- Are there results?
- Not yet: the study is under way
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.
Latvia1 site, 1 recruiting
- Recruiting
Laboratory of Sports and Nutrition Research
Riga, Dzirciema Street 16, LV1007
Dace Reihmane, PhD, +37126032249, Dace.Reihmane@rsu.lv
lsnr@rsu.lv
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.
- Conditions
- Acute Exercise, Breast Cancer Cell Lines, Breast Cancer Survivors, Healthy Women, Myokine Response
- 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 group | Role | What they receive |
|---|---|---|
| Breast Cancer Survivors | Experimental | Premenopausal breast cancer survivors (diagnosed with TNBC) 35 years old or older Receives: Other: High intensity continuous exercise; Other: Moderate intensity continuous exercise |
| Healthy women | Active comparator | Healthy 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.
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).
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)
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.
- First posted27 Feb 2026
- Study start1 Apr 2024
- Primary completion31 Mar 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Riga Stradins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dace Reihmane, Riga Stradins University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07439458
- Acronym / sponsor ID
- TCReX / 2-PĒK-4/604/2025
- Conditions
- Acute Exercise, Breast Cancer Cell Lines, Breast Cancer Survivors, Healthy Women, Myokine Response
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riga Stradins UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Survivors | Experimental | Other: High intensity continuous exercise, Other: Moderate intensity continuous exercisePremenopausal breast cancer survivors (diagnosed with TNBC) 35 years old or older |
| Healthy women | Active comparator | Other: High intensity continuous exercise, Other: Moderate intensity continuous exerciseHealthy premenopausal women 35 years old or older |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity continuous exercise30 minutes of continuous exercise at 75% of VO2max, additionally 15 minutes of warm-up to reach specific workload. | Other | Breast Cancer Survivors, Healthy women |
| Moderate intensity continuous exercise30 minutes of continuous exercise at 45% of VO2max, additionally 15 minutes of warm-up to reach specific workload. | Other | Breast Cancer Survivors, Healthy women |
Primary outcome
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).
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.
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).
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dace Reihmane, PhD (+37126032249, Dace.Reihmane@rsu.lv), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.