Breast CancerCancerBeatNCT06522971
Effects of Physical Exercise on Response to Treatement in Breast Cancer
A study testing High-intensiy interval training in people with Breast Cancer, run by Latvian Biomedical Research and Study Centre at 1 site in Latvia.
Trial summary
The goal of this clinical trial is to learn how regular physical exercise affects breast cancer patients' response to standard neoadjuvant chemotherapy (NAC) and to gain an insight into the molecular mechanisms underlying the effects of exercise on cancer biology. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- High-intensiy interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteLatvia
- Study dates
- 16 Aug 2022to 30 Dec 2027
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary breast cancer; stage IIA-B, IIIA-C (TNM: T1-4, N0-3, M0) at diagnosis
- Diagnosis established by core needle biopsy
- Age 30-65 years
- Prescribed doxorubicin/cyclophosphamide-based NAC
- Oral and written consent
Who cannot join
- Cardiac pathologies
- Pregnancy
- Blood transfusion in the last six months
- Another oncological disease
- Previous chemotherapy, hormonal or X-ray treatment
- Participation in another clinical trial
- Currently performing more than 180 min of moderate to high intensity aerobic training per week
Trial locations and contacts
1 site in 1 country.
Latvia1 site
Latvian Biomedical Research and Study centre
Riga, Select One, LV1067
About this study
Official title: Exploration of the Molecular Mechanisms Behind the Effects of Physical Exercise on Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
The goal of this clinical trial is to learn how regular physical exercise affects breast cancer patients' response to standard neoadjuvant chemotherapy (NAC) and to gain an insight into the molecular mechanisms underlying the effects of exercise on cancer biology. of exercise-induced alterations in cancer gene expression and the immune tumor microenvironment. The main questions it aims to answer are:
- Does a high-intensity interval training (HIIT) program during treatment improve patients' response to NAC and quality of life as compared to low level of physical activity during the treatment?
- What are the differences in the residual tumor gene expression and tumor infiltrating immune cell profile between patients taking HIIT during the NAC and patients with low level of physical activity?
- What are the roles of extracellular vesicles (EVs) in mediating the effects of exercise on cancer progression?
Patients in HIIT group will undergo a personalized HIIT program consisting of 3 training sessions per week for the whole duration of NAC, whereas patients from the control group (Ctrl) will be advised to maintain their usual level of physical activity during NAC. After the breast surgery, response to NAC will be assessed by Miller-Payne grading. Tumor and normal breast tissue specimens will be collected for RNA sequencing analysis. Blood samples will be collected before and immediately after the training for the analysis of RNA and protein cargo of circulating EVs.
- Conditions
- Breast Cancer
- Being tested
- High-intensiy interval training
- Keywords
- High intensity interval training
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensiy interval trainingBehavioural
All participants undergo physical capacity tests before the onset of NAC and after the last course of NAC but before the breast cancer surgery. A treadmill protocol consisting of twenty-one 1-minute stages, with speed and/or grade increments at each stage, is used to obtain VO2 peak (the highest amount of oxygen consumed at peak exercise) data. The HIIT intervention consists of 2 to 3 exercise sessions per week for 6 months. The HIIT session starts with a 6-minute warm-up period at about 65-70% of maximal heart rate (HRmax) followed by 4 X 4-min high-intensity intervals (85%-95% of HRmax) combined with 3 min period of active recovery (55-70% of HRmax).
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training (HIIT) | Experimental | High-intensity interval training during neoadjuvant chemotherapy Receives: Behavioral: High-intensiy interval training |
| Low level of physical activity (CON) | No intervention | Advised to maintain usual level of physical activity during neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miller-Payne grade
Response to NAC assessed by histological examination of residual tumor at surgery using Miller-Payne grading from 1 to 5, where grade 1 means no response or some alterations to individual malignant cells but no reduction in overall cellularity, whereas grade 5 is a pathological complete response.
Measured: 6 months
Gene expression profile
Alterations in the tumor gene expression profile will be assessed by RNA sequencing of surgical tumor and normal breast tissue specimens
Measured: 12 months
Secondary outcomes (8)
RNA cargo of extracellular vesicles
Exercise-induced alterations in the RNA cargo of circulating extracellular vesicles will be studied by RNA sequencing
Measured: Before intervention and after 6 months
Protein cargo of extracellular vesicles
Exercise-induced alterations in the protein cargo of circulating extracellular vesicles will be studied by proteomic analysis
Measured: Before intervention and after 6 months
Number and phenotype of tumor-infiltrating immune cells
Immunophenotyping of tumor-infiltrating immune cells will be performed by multiplex immunofluorescence in breast tumor tissue specimens
Measured: 12 months
Global health-related quality of life
Global health-related quality of life will be assessed by the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30). All scales and single-item measures yield scores ranging from 0 to 100. A high score on a functional scale indicates superior functioning and a high score on the global health status/QoL scale indicates a high quality of life. Conversely, a high score on a symptom scale or item indicates a heightened level of health complaints and/ or presence of treatment side effects.
Measured: 6 months
Breast cancer-related quality of life
Breast cancer-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Breast cancer module (EORTC QLQ-B23) questionnaire that includes 23 questions addressing disease symptoms, treatment side effects, body image, sexual functioning, and future perspectives. All scales and single-item measures yield scores ranging from 0 to 100.
Measured: 6 months
VO2 peak
Oxygen peak consumption will be measured by UNCCRI treadmill protocol
Measured: Before intervention and after 6 months
30 sec sit-to-stand test
The number of sit- and stand-up movement repetitions achieved during 30 sec will be recorded
Measured: Before intervention and after 6 months
6-minute walk test
The test will be performed indoors on 30 m long testing course and length of walked distance will be measured
Measured: Before intervention and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start16 Aug 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latvian Biomedical Research and Study Centre
- Sponsor type
- Other government
- Collaborators
- Riga East Clinical University Hospital, Latvian Academy of Sport Education
- Responsible party
- Sponsor
- Investigators
- Aija Linē, PhD, Principal investigator, Latvian Biomedical Research and Study Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522971
- Sponsor's protocol ID
- NFI_164
- Acronym
- CancerBeat
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore SC, Lee IM, Weiderpass E, Campbell PT, Sampson JN, Kitahara CM, Keadle SK, Arem H, Berrington de Gonzalez A, Hartge P, Adami HO, Blair CK, Borch KB, Boyd E, Check DP, Fournier A, Freedman ND, Gunter M, Johannson M, Khaw KT, Linet MS, Orsini N, Park Y, Riboli E, Robien K, Schairer C, Sesso H, Spriggs M, Van Dusen R, Wolk A, Matthews CE, Patel AV. Association of Leisure-Time Physical Activity With Risk of 26 Types of Cancer in 1.44 Million Adults. JAMA Intern Med. 2016 Jun 1;176(6):816-25. doi: 10.1001/jamainternmed.2016.1548.
PubMed 27183032Matthews CE, Moore SC, Arem H, Cook MB, Trabert B, Hakansson N, Larsson SC, Wolk A, Gapstur SM, Lynch BM, Milne RL, Freedman ND, Huang WY, Berrington de Gonzalez A, Kitahara CM, Linet MS, Shiroma EJ, Sandin S, Patel AV, Lee IM. Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk. J Clin Oncol. 2020 Mar 1;38(7):686-697. doi: 10.1200/JCO.19.02407. Epub 2019 Dec 26.
PubMed 31877085Hornsby WE, Douglas PS, West MJ, Kenjale AA, Lane AR, Schwitzer ER, Ray KA, Herndon JE 2nd, Coan A, Gutierrez A, Hornsby KP, Hamilton E, Wilke LG, Kimmick GG, Peppercorn JM, Jones LW. Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Acta Oncol. 2014 Jan;53(1):65-74. doi: 10.3109/0284186X.2013.781673. Epub 2013 Aug 19.
PubMed 23957716Mijwel S, Backman M, Bolam KA, Olofsson E, Norrbom J, Bergh J, Sundberg CJ, Wengstrom Y, Rundqvist H. Highly favorable physiological responses to concurrent resistance and high-intensity interval training during chemotherapy: the OptiTrain breast cancer trial. Breast Cancer Res Treat. 2018 May;169(1):93-103. doi: 10.1007/s10549-018-4663-8. Epub 2018 Jan 18.
PubMed 29349712Li Y, Xiao X, Zhang Y, Tang W, Zhong D, Liu T, Zhu Y, Li J, Jin R. Effect of Exercise on Breast Cancer: A Systematic Review and Meta-analysis of Animal Experiments. Front Mol Biosci. 2022 Jun 6;9:843810. doi: 10.3389/fmolb.2022.843810. eCollection 2022.
PubMed 35733941Hagar A, Wang Z, Koyama S, Serrano JA, Melo L, Vargas S, Carpenter R, Foley J. Endurance training slows breast tumor growth in mice by suppressing Treg cells recruitment to tumors. BMC Cancer. 2019 Jun 4;19(1):536. doi: 10.1186/s12885-019-5745-7.
PubMed 31164094Wennerberg E, Lhuillier C, Rybstein MD, Dannenberg K, Rudqvist NP, Koelwyn GJ, Jones LW, Demaria S. Exercise reduces immune suppression and breast cancer progression in a preclinical model. Oncotarget. 2020 Jan 28;11(4):452-461. doi: 10.18632/oncotarget.27464. eCollection 2020 Jan 28.
PubMed 32064049Pedersen L, Idorn M, Olofsson GH, Lauenborg B, Nookaew I, Hansen RH, Johannesen HH, Becker JC, Pedersen KS, Dethlefsen C, Nielsen J, Gehl J, Pedersen BK, Thor Straten P, Hojman P. Voluntary Running Suppresses Tumor Growth through Epinephrine- and IL-6-Dependent NK Cell Mobilization and Redistribution. Cell Metab. 2016 Mar 8;23(3):554-62. doi: 10.1016/j.cmet.2016.01.011. Epub 2016 Feb 16.
PubMed 26895752Yanez-Mo M, Siljander PR, Andreu Z, Zavec AB, Borras FE, Buzas EI, Buzas K, Casal E, Cappello F, Carvalho J, Colas E, Cordeiro-da Silva A, Fais S, Falcon-Perez JM, Ghobrial IM, Giebel B, Gimona M, Graner M, Gursel I, Gursel M, Heegaard NH, Hendrix A, Kierulf P, Kokubun K, Kosanovic M, Kralj-Iglic V, Kramer-Albers EM, Laitinen S, Lasser C, Lener T, Ligeti E, Line A, Lipps G, Llorente A, Lotvall J, Mancek-Keber M, Marcilla A, Mittelbrunn M, Nazarenko I, Nolte-'t Hoen EN, Nyman TA, O'Driscoll L, Olivan M, Oliveira C, Pallinger E, Del Portillo HA, Reventos J, Rigau M, Rohde E, Sammar M, Sanchez-Madrid F, Santarem N, Schallmoser K, Ostenfeld MS, Stoorvogel W, Stukelj R, Van der Grein SG, Vasconcelos MH, Wauben MH, De Wever O. Biological properties of extracellular vesicles and their physiological functions. J Extracell Vesicles. 2015 May 14;4:27066. doi: 10.3402/jev.v4.27066. eCollection 2015.
PubMed 25979354Fruhbeis C, Helmig S, Tug S, Simon P, Kramer-Albers EM. Physical exercise induces rapid release of small extracellular vesicles into the circulation. J Extracell Vesicles. 2015 Jul 2;4:28239. doi: 10.3402/jev.v4.28239. eCollection 2015.
PubMed 26142461Sadovska L, Auders J, Keisa L, Romanchikova N, Silamikele L, Kreismane M, Zayakin P, Takahashi S, Kalnina Z, Line A. Exercise-Induced Extracellular Vesicles Delay the Progression of Prostate Cancer. Front Mol Biosci. 2022 Jan 11;8:784080. doi: 10.3389/fmolb.2021.784080. eCollection 2021.
PubMed 35087866Skorinkina D, Eglitis K, Zayakin P, Mlynska A, Martin-Gracia B, Bassols-Citores E, Sadovska L, Brokane A, Rise F, Sagini K, Romero S, Gkelis K, Zablocka T, Campa M, Ceseiko R, Klavina A, Liepniece-Karele I, Eglitis J, Silina K, Llorente A, Line A. Home-based high-intensity exercise training during neoadjuvant chemotherapy is associated with favorable chemotherapy outcomes and tumor microenvironment remodeling in breast cancer. Cell Commun Signal. 2026 Jul 10. doi: 10.1186/s12964-026-03053-1. Online ahead of print.
PubMed 42432678
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Molecular Mechanisms Behind the Effects of Physical Exercise on Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06522971
- Acronym / sponsor ID
- CancerBeat / NFI_164
- Conditions
- Breast Cancer
- Keywords
- High intensity interval training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Latvian Biomedical Research and Study CentreOther government
- Collaborators
- Riga East Clinical University Hospital, Latvian Academy of Sport Education
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Jul 2024 (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.
The goal of this clinical trial is to learn how regular physical exercise affects breast cancer patients' response to standard neoadjuvant chemotherapy (NAC) and to gain an insight into the molecular mechanisms underlying the effects of exercise on cancer biology. of exercise-induced alterations in cancer gene expression and the immune tumor microenvironment. The main questions it aims to answer are:
- Does a high-intensity interval training (HIIT) program during treatment improve patients' response to NAC and quality of life as compared to low level of physical activity during the treatment?
- What are the differences in the residual tumor gene expression and tumor infiltrating immune cell profile between patients taking HIIT during the NAC and patients with low level of physical activity?
- What are the roles of extracellular vesicles (EVs) in mediating the effects of exercise on cancer progression?
Patients in HIIT group will undergo a personalized HIIT program consisting of 3 training sessions per week for the whole duration of NAC, whereas patients from the control group (Ctrl) will be advised to maintain their usual level of physical activity during NAC. After the breast surgery, response to NAC will be assessed by Miller-Payne grading. Tumor and normal breast tissue specimens will be collected for RNA sequencing analysis. Blood samples will be collected before and immediately after the training for the analysis of RNA and protein cargo of circulating EVs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training (HIIT) | Experimental | Behavioral: High-intensiy interval trainingHigh-intensity interval training during neoadjuvant chemotherapy |
| Low level of physical activity (CON) | No intervention | –Advised to maintain usual level of physical activity during neoadjuvant chemotherapy |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary breast cancer; stage IIA-B, IIIA-C (TNM: T1-4, N0-3, M0) at diagnosis
- Diagnosis established by core needle biopsy
- Age 30-65 years
- Prescribed doxorubicin/cyclophosphamide-based NAC
- Oral and written consent
Key exclusion criteria (7 listed)
- Cardiac pathologies
- Pregnancy
- Blood transfusion in the last six months
- Another oncological disease
- Previous chemotherapy, hormonal or X-ray treatment
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-intensiy interval trainingAll participants undergo physical capacity tests before the onset of NAC and after the last course of NAC but before the breast cancer surgery. A treadmill protocol consisting of twenty-one 1-minute stages, with speed and/or grade increments at each stage, is used to obtain VO2 peak (the highest amount of oxygen consumed at peak exercise) data. The HIIT intervention consists of 2 to 3 exercise sessions per week for 6 months. The HIIT session starts with a 6-minute warm-up period at about 65-70% of maximal heart rate (HRmax) followed by 4 X 4-min high-intensity intervals (85%-95% of HRmax) combined with 3 min period of active recovery (55-70% of HRmax). | Behavioural | High-intensity interval training (HIIT) |
Primary outcome
Miller-Payne grade
Time frame: 6 months
Response to NAC assessed by histological examination of residual tumor at surgery using Miller-Payne grading from 1 to 5, where grade 1 means no response or some alterations to individual malignant cells but no reduction in overall cellularity, whereas grade 5 is a pathological complete response.
Gene expression profile
Time frame: 12 months
Alterations in the tumor gene expression profile will be assessed by RNA sequencing of surgical tumor and normal breast tissue specimens
8 secondary outcomes
RNA cargo of extracellular vesicles
Time frame: Before intervention and after 6 months
Protein cargo of extracellular vesicles
Time frame: Before intervention and after 6 months
Number and phenotype of tumor-infiltrating immune cells
Time frame: 12 months
Global health-related quality of life
Time frame: 6 months
Breast cancer-related quality of life
Time frame: 6 months
VO2 peak
Time frame: Before intervention and after 6 months
30 sec sit-to-stand test
Time frame: Before intervention and after 6 months
6-minute walk test
Time frame: Before intervention and after 6 months
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 10 Sep 2025.
- Background: PubMed 27183032Moore SC, Lee IM, Weiderpass E, Campbell PT, Sampson JN, Kitahara CM, Keadle SK, Arem H, Berrington de Gonzalez A, Hartge P, Adami HO, Blair CK, Borch KB, Boyd E, Check DP, Fournier A, Freedman ND, Gunter M, Johannson M, Khaw KT, Linet MS, Orsini N, Park Y, Riboli E, Robien K, Schairer C, Sesso H, Spriggs M, Van Dusen R, Wolk A, Matthews CE, Patel AV. Association of Leisure-Time Physical Activity With Risk of 26 Types of Cancer in 1.44 Million Adults. JAMA Intern Med. 2016 Jun 1;176(6):816-25. doi: 10.1001/jamainternmed.2016.1548.
- Background: PubMed 31877085Matthews CE, Moore SC, Arem H, Cook MB, Trabert B, Hakansson N, Larsson SC, Wolk A, Gapstur SM, Lynch BM, Milne RL, Freedman ND, Huang WY, Berrington de Gonzalez A, Kitahara CM, Linet MS, Shiroma EJ, Sandin S, Patel AV, Lee IM. Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk. J Clin Oncol. 2020 Mar 1;38(7):686-697. doi: 10.1200/JCO.19.02407. Epub 2019 Dec 26.
- Background: PubMed 23957716Hornsby WE, Douglas PS, West MJ, Kenjale AA, Lane AR, Schwitzer ER, Ray KA, Herndon JE 2nd, Coan A, Gutierrez A, Hornsby KP, Hamilton E, Wilke LG, Kimmick GG, Peppercorn JM, Jones LW. Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial. Acta Oncol. 2014 Jan;53(1):65-74. doi: 10.3109/0284186X.2013.781673. Epub 2013 Aug 19.
- Background: PubMed 29349712Mijwel S, Backman M, Bolam KA, Olofsson E, Norrbom J, Bergh J, Sundberg CJ, Wengstrom Y, Rundqvist H. Highly favorable physiological responses to concurrent resistance and high-intensity interval training during chemotherapy: the OptiTrain breast cancer trial. Breast Cancer Res Treat. 2018 May;169(1):93-103. doi: 10.1007/s10549-018-4663-8. Epub 2018 Jan 18.
- Background: PubMed 35733941Li Y, Xiao X, Zhang Y, Tang W, Zhong D, Liu T, Zhu Y, Li J, Jin R. Effect of Exercise on Breast Cancer: A Systematic Review and Meta-analysis of Animal Experiments. Front Mol Biosci. 2022 Jun 6;9:843810. doi: 10.3389/fmolb.2022.843810. eCollection 2022.
- Background: PubMed 31164094Hagar A, Wang Z, Koyama S, Serrano JA, Melo L, Vargas S, Carpenter R, Foley J. Endurance training slows breast tumor growth in mice by suppressing Treg cells recruitment to tumors. BMC Cancer. 2019 Jun 4;19(1):536. doi: 10.1186/s12885-019-5745-7.
- Background: PubMed 32064049Wennerberg E, Lhuillier C, Rybstein MD, Dannenberg K, Rudqvist NP, Koelwyn GJ, Jones LW, Demaria S. Exercise reduces immune suppression and breast cancer progression in a preclinical model. Oncotarget. 2020 Jan 28;11(4):452-461. doi: 10.18632/oncotarget.27464. eCollection 2020 Jan 28.
- Background: PubMed 26895752Pedersen L, Idorn M, Olofsson GH, Lauenborg B, Nookaew I, Hansen RH, Johannesen HH, Becker JC, Pedersen KS, Dethlefsen C, Nielsen J, Gehl J, Pedersen BK, Thor Straten P, Hojman P. Voluntary Running Suppresses Tumor Growth through Epinephrine- and IL-6-Dependent NK Cell Mobilization and Redistribution. Cell Metab. 2016 Mar 8;23(3):554-62. doi: 10.1016/j.cmet.2016.01.011. Epub 2016 Feb 16.
- Background: PubMed 25979354Yanez-Mo M, Siljander PR, Andreu Z, Zavec AB, Borras FE, Buzas EI, Buzas K, Casal E, Cappello F, Carvalho J, Colas E, Cordeiro-da Silva A, Fais S, Falcon-Perez JM, Ghobrial IM, Giebel B, Gimona M, Graner M, Gursel I, Gursel M, Heegaard NH, Hendrix A, Kierulf P, Kokubun K, Kosanovic M, Kralj-Iglic V, Kramer-Albers EM, Laitinen S, Lasser C, Lener T, Ligeti E, Line A, Lipps G, Llorente A, Lotvall J, Mancek-Keber M, Marcilla A, Mittelbrunn M, Nazarenko I, Nolte-'t Hoen EN, Nyman TA, O'Driscoll L, Olivan M, Oliveira C, Pallinger E, Del Portillo HA, Reventos J, Rigau M, Rohde E, Sammar M, Sanchez-Madrid F, Santarem N, Schallmoser K, Ostenfeld MS, Stoorvogel W, Stukelj R, Van der Grein SG, Vasconcelos MH, Wauben MH, De Wever O. Biological properties of extracellular vesicles and their physiological functions. J Extracell Vesicles. 2015 May 14;4:27066. doi: 10.3402/jev.v4.27066. eCollection 2015.
- Background: PubMed 26142461Fruhbeis C, Helmig S, Tug S, Simon P, Kramer-Albers EM. Physical exercise induces rapid release of small extracellular vesicles into the circulation. J Extracell Vesicles. 2015 Jul 2;4:28239. doi: 10.3402/jev.v4.28239. eCollection 2015.
- Background: PubMed 35087866Sadovska L, Auders J, Keisa L, Romanchikova N, Silamikele L, Kreismane M, Zayakin P, Takahashi S, Kalnina Z, Line A. Exercise-Induced Extracellular Vesicles Delay the Progression of Prostate Cancer. Front Mol Biosci. 2022 Jan 11;8:784080. doi: 10.3389/fmolb.2021.784080. eCollection 2021.
- Derived from this study: PubMed 42432678Skorinkina D, Eglitis K, Zayakin P, Mlynska A, Martin-Gracia B, Bassols-Citores E, Sadovska L, Brokane A, Rise F, Sagini K, Romero S, Gkelis K, Zablocka T, Campa M, Ceseiko R, Klavina A, Liepniece-Karele I, Eglitis J, Silina K, Llorente A, Line A. Home-based high-intensity exercise training during neoadjuvant chemotherapy is associated with favorable chemotherapy outcomes and tumor microenvironment remodeling in breast cancer. Cell Commun Signal. 2026 Jul 10. doi: 10.1186/s12964-026-03053-1. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aija Linē, PhD principal investigator
Latvian Biomedical Research and Study Centre
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-intensiy interval training in people with Breast Cancer, run by Latvian Biomedical Research and Study Centre 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miller-Payne grade (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT06522971, which also lists 12 linked publications.
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 10 Sep 2025.