Breast CancerWIM_22NCT05882578
Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals
A study testing Oncological physical exercise intervention and Active Physical Activities intervention in people with Breast Cancer and Cancer Survivors, run by Tigers Running Club at 1 site in Spain.
Trial summary
The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are: Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cancer Survivors
- What is being tested?
- Oncological physical exercise intervention and Active Physical Activities intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women diagnosed with primary, type I to III A/B cancer, with hormonal positive (ER+ and PG+), triple positive (ER+, PG+ y HER2+) or triple negative subtype.
- Women with chemotherapy and radiotherapy phase complete.
- Women with post-surgery phase complete.
- Women that are within 5 years from diagnostic.
- ECOG Score above or equal to 0 or 1.
Who cannot join
- Submit medical contraindications to physical exercise by their reference doctor.
- Women in state IV o methastasis.
- Pregnant women.
- Meet any of the criteria of the American Thoracic Society (ATS) to perfrom a cardiovascular fitness test.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are:
- Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants.
- Analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants
Read more
Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks.
Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.
- Conditions
- Breast Cancer, Cancer Survivors
- Being tested
- Oncological physical exercise intervention, Active Physical Activities intervention
- Keywords
- Breast Cancer, Exercise Oncology, Cancer Survivors, Fitness Capacity, Quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncological physical exercise interventionOther
An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested.
Patients will be screened and then divided in diferent groups, depending on both their cardiovascular and physical capacity.
Then they will perform 2 sessions of combined strength and endurance training per week for 16 weeks.
At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.
Active Physical Activities interventionOther
An initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested Patients will be suggested to mantain active physical activities in their daily life.
At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients will be assessed and screened prior the intervention. After the physical assestment they will attend 2 days a week for the supervised, and controlled sessions of physical exercise, performed in the nature (Retiro park in Madrid). To meassure the intensity of the program, they will use the 1-10 Borg ratio of perceived exertion (RPE). Receives: Other: Oncological physical exercise intervention |
| Control Group | Active comparator | Patients will be asked to mantain an active lifestyle, performing physical activity regularly. Receives: Other: Active Physical Activities intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular fitness
Evaluate the effectiveness of the program in the improvement of the cardiovascular capacity in breast cancer survivors (looking for a difference of 3,49 ml/kg/min of oxigen consumption), using a submaximal cardiovascular test.
Measured: 16 weeks
Secondary outcomes (7)
Body composition
Analyze the effect of the oncologic physical exercise program in the body weight, the body mass index (BMI), percentages in body fat, abdominal fat, fat free mass, bone mass and total body water in breast cancer survivors.
Measured: 16 weeks
Physical functionality
Know the impact of the oncologic physical exercise program in the physical functionality of the patients.
Measured: 16 weeks
Exercise adherence
Measure the level of adherence to the oncologic physical exercise program, registering the assistance to the sessions.
Measured: 16 weeks
Physical activity Levels
Evaluate the effect of the intervention in the physical activity levels performed by the patients.
Measured: 16 weeks
Fatigue levels
Evaluate the impact of the physical exercise program in the fatigue levels of the participants.
Measured: 16weeks
Quality of life and health
Evaluate the impact of the oncological physical exercise program in the quality of life of the patients in relation with their health.
Measured: 16 weeks
Anxiety and depression levels
Analyze the impact of the oncologic physical exercise program in the anxiety and depression levels of the subjects.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start12 Jan 2023
- Primary completion9 Apr 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- control trial
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tigers Running Club
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soraya Casla Barrio, Tigers Running Club
- Investigators
- Soraya Casla-Barrio, PhD, Principal investigator, Tigers Running ClubHelios Pareja-Galeano, PhD, Study chair, Universidad Autonoma de MadridMónica Castellanos, MSc, Study chair, Tigers Running ClubJaime Pérez-Vélez, BSc, Study chair, Tigers Running Club
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882578
- Sponsor's protocol ID
- WIM_SURVIVALS_22
- Acronym
- WIM_22
- Status last verified
- Dec 2024
- First submitted
- 22 May 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information will be shared with the patients after the completion of every test. This information will be shared only with the participant researchers of this study.
Publications
Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, Cannady RS, Pratt-Chapman ML, Edge SB, Jacobs LA, Hurria A, Marks LB, LaMonte SJ, Warner E, Lyman GH, Ganz PA. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. CA Cancer J Clin. 2016 Jan-Feb;66(1):43-73. doi: 10.3322/caac.21319. Epub 2015 Dec 7.
PubMed 26641959Wang H, Mao X. Evaluation of the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer. Drug Des Devel Ther. 2020 Jun 18;14:2423-2433. doi: 10.2147/DDDT.S253961. eCollection 2020.
PubMed 32606609Fisusi FA, Akala EO. Drug Combinations in Breast Cancer Therapy. Pharm Nanotechnol. 2019;7(1):3-23. doi: 10.2174/2211738507666190122111224.
PubMed 30666921Nicolazzi MA, Carnicelli A, Fuorlo M, Scaldaferri A, Masetti R, Landolfi R, Favuzzi AMR. Anthracycline and trastuzumab-induced cardiotoxicity in breast cancer. Eur Rev Med Pharmacol Sci. 2018 Apr;22(7):2175-2185. doi: 10.26355/eurrev_201804_14752.
PubMed 29687878Minotti G, Menna P, Salvatorelli E, Cairo G, Gianni L. Anthracyclines: molecular advances and pharmacologic developments in antitumor activity and cardiotoxicity. Pharmacol Rev. 2004 Jun;56(2):185-229. doi: 10.1124/pr.56.2.6.
PubMed 15169927Kotamraju S, Chitambar CR, Kalivendi SV, Joseph J, Kalyanaraman B. Transferrin receptor-dependent iron uptake is responsible for doxorubicin-mediated apoptosis in endothelial cells: role of oxidant-induced iron signaling in apoptosis. J Biol Chem. 2002 May 10;277(19):17179-87. doi: 10.1074/jbc.M111604200. Epub 2002 Feb 20.
PubMed 11856741Bikiewicz A, Banach M, von Haehling S, Maciejewski M, Bielecka-Dabrowa A. Adjuvant breast cancer treatments cardiotoxicity and modern methods of detection and prevention of cardiac complications. ESC Heart Fail. 2021 Aug;8(4):2397-2418. doi: 10.1002/ehf2.13365. Epub 2021 May 5.
PubMed 33955207Padegimas A, Clasen S, Ky B. Cardioprotective strategies to prevent breast cancer therapy-induced cardiotoxicity. Trends Cardiovasc Med. 2020 Jan;30(1):22-28. doi: 10.1016/j.tcm.2019.01.006. Epub 2019 Jan 29.
PubMed 30745071Cardinale D, Iacopo F, Cipolla CM. Cardiotoxicity of Anthracyclines. Front Cardiovasc Med. 2020 Mar 18;7:26. doi: 10.3389/fcvm.2020.00026. eCollection 2020.
PubMed 32258060Armenian SH, Xu L, Ky B, Sun C, Farol LT, Pal SK, Douglas PS, Bhatia S, Chao C. Cardiovascular Disease Among Survivors of Adult-Onset Cancer: A Community-Based Retrospective Cohort Study. J Clin Oncol. 2016 Apr 1;34(10):1122-30. doi: 10.1200/JCO.2015.64.0409. Epub 2016 Feb 1.
PubMed 26834065Abdel-Qadir H, Austin PC, Lee DS, Amir E, Tu JV, Thavendiranathan P, Fung K, Anderson GM. A Population-Based Study of Cardiovascular Mortality Following Early-Stage Breast Cancer. JAMA Cardiol. 2017 Jan 1;2(1):88-93. doi: 10.1001/jamacardio.2016.3841.
PubMed 27732702Cardinale D, Colombo A, Bacchiani G, Tedeschi I, Meroni CA, Veglia F, Civelli M, Lamantia G, Colombo N, Curigliano G, Fiorentini C, Cipolla CM. Early detection of anthracycline cardiotoxicity and improvement with heart failure therapy. Circulation. 2015 Jun 2;131(22):1981-8. doi: 10.1161/CIRCULATIONAHA.114.013777. Epub 2015 May 6.
PubMed 25948538Jones LW, Eves ND, Haykowsky M, Freedland SJ, Mackey JR. Exercise intolerance in cancer and the role of exercise therapy to reverse dysfunction. Lancet Oncol. 2009 Jun;10(6):598-605. doi: 10.1016/S1470-2045(09)70031-2.
PubMed 19482248Hurria A, Jones L, Muss HB. Cancer Treatment as an Accelerated Aging Process: Assessment, Biomarkers, and Interventions. Am Soc Clin Oncol Educ Book. 2016;35:e516-22. doi: 10.1200/EDBK_156160.
PubMed 27249761Jones LW, Courneya KS, Mackey JR, Muss HB, Pituskin EN, Scott JM, Hornsby WE, Coan AD, Herndon JE 2nd, Douglas PS, Haykowsky M. Cardiopulmonary function and age-related decline across the breast cancer survivorship continuum. J Clin Oncol. 2012 Jul 10;30(20):2530-7. doi: 10.1200/JCO.2011.39.9014. Epub 2012 May 21.
PubMed 22614980
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Oncology Intervention in Fitness Capacity and Body Composition in Breast Cancer Survivals
- ClinicalTrials.gov ID
- NCT05882578
- Acronym / sponsor ID
- WIM_22 / WIM_SURVIVALS_22
- Conditions
- Breast Cancer, Cancer Survivors
- Keywords
- Breast Cancer, Exercise Oncology, Cancer Survivors, Fitness Capacity, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tigers Running ClubUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 31 May 2023 (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 interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. The main questions it aims to answer are:
- Evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants.
- Analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants
Participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks.
Researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Oncological physical exercise interventionPatients will be assessed and screened prior the intervention. After the physical assestment they will attend 2 days a week for the supervised, and controlled sessions of physical exercise, performed in the nature (Retiro park in Madrid). To meassure the intensity of the program, they will use the 1-10 Borg ratio of perceived exertion (RPE). |
| Control Group | Active comparator | Other: Active Physical Activities interventionPatients will be asked to mantain an active lifestyle, performing physical activity regularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women diagnosed with primary, type I to III A/B cancer, with hormonal positive (ER+ and PG+), triple positive (ER+, PG+ y HER2+) or triple negative subtype.
- Women with chemotherapy and radiotherapy phase complete.
- Women with post-surgery phase complete.
- Women that are within 5 years from diagnostic.
- ECOG Score above or equal to 0 or 1.
Key exclusion criteria (4 listed)
- Submit medical contraindications to physical exercise by their reference doctor.
- Women in state IV o methastasis.
- Pregnant women.
- Meet any of the criteria of the American Thoracic Society (ATS) to perfrom a cardiovascular fitness test.
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 |
|---|---|---|
| Oncological physical exercise interventionAn initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested. Patients will be screened and then divided in diferent groups, depending on both their cardiovascular and physical capacity. Then they will perform 2 sessions of combined strength and endurance training per week for 16 weeks. At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life. | Other | Intervention Group |
| Active Physical Activities interventionAn initial physical assestment where clinical history, body composition, functionality, cardiovascular fitness and quality of life will be tested Patients will be suggested to mantain active physical activities in their daily life. At the end of the training program, the patients will be assesed to evaluate the changes in their cardiovascular fitness, functionality, body composition and quality of life. | Other | Control Group |
Primary outcome
Cardiovascular fitness
Time frame: 16 weeks
Evaluate the effectiveness of the program in the improvement of the cardiovascular capacity in breast cancer survivors (looking for a difference of 3,49 ml/kg/min of oxigen consumption), using a submaximal cardiovascular test.
7 secondary outcomes
Body composition
Time frame: 16 weeks
Physical functionality
Time frame: 16 weeks
Exercise adherence
Time frame: 16 weeks
Physical activity Levels
Time frame: 16 weeks
Fatigue levels
Time frame: 16weeks
Quality of life and health
Time frame: 16 weeks
Anxiety and depression levels
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 26641959Runowicz CD, Leach CR, Henry NL, Henry KS, Mackey HT, Cowens-Alvarado RL, Cannady RS, Pratt-Chapman ML, Edge SB, Jacobs LA, Hurria A, Marks LB, LaMonte SJ, Warner E, Lyman GH, Ganz PA. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline. CA Cancer J Clin. 2016 Jan-Feb;66(1):43-73. doi: 10.3322/caac.21319. Epub 2015 Dec 7.
- Background: PubMed 32606609Wang H, Mao X. Evaluation of the Efficacy of Neoadjuvant Chemotherapy for Breast Cancer. Drug Des Devel Ther. 2020 Jun 18;14:2423-2433. doi: 10.2147/DDDT.S253961. eCollection 2020.
- Background: PubMed 30666921Fisusi FA, Akala EO. Drug Combinations in Breast Cancer Therapy. Pharm Nanotechnol. 2019;7(1):3-23. doi: 10.2174/2211738507666190122111224.
- Background: PubMed 29687878Nicolazzi MA, Carnicelli A, Fuorlo M, Scaldaferri A, Masetti R, Landolfi R, Favuzzi AMR. Anthracycline and trastuzumab-induced cardiotoxicity in breast cancer. Eur Rev Med Pharmacol Sci. 2018 Apr;22(7):2175-2185. doi: 10.26355/eurrev_201804_14752.
- Background: PubMed 15169927Minotti G, Menna P, Salvatorelli E, Cairo G, Gianni L. Anthracyclines: molecular advances and pharmacologic developments in antitumor activity and cardiotoxicity. Pharmacol Rev. 2004 Jun;56(2):185-229. doi: 10.1124/pr.56.2.6.
- Background: PubMed 11856741Kotamraju S, Chitambar CR, Kalivendi SV, Joseph J, Kalyanaraman B. Transferrin receptor-dependent iron uptake is responsible for doxorubicin-mediated apoptosis in endothelial cells: role of oxidant-induced iron signaling in apoptosis. J Biol Chem. 2002 May 10;277(19):17179-87. doi: 10.1074/jbc.M111604200. Epub 2002 Feb 20.
- Background: PubMed 33955207Bikiewicz A, Banach M, von Haehling S, Maciejewski M, Bielecka-Dabrowa A. Adjuvant breast cancer treatments cardiotoxicity and modern methods of detection and prevention of cardiac complications. ESC Heart Fail. 2021 Aug;8(4):2397-2418. doi: 10.1002/ehf2.13365. Epub 2021 May 5.
- Background: PubMed 30745071Padegimas A, Clasen S, Ky B. Cardioprotective strategies to prevent breast cancer therapy-induced cardiotoxicity. Trends Cardiovasc Med. 2020 Jan;30(1):22-28. doi: 10.1016/j.tcm.2019.01.006. Epub 2019 Jan 29.
- Background: PubMed 32258060Cardinale D, Iacopo F, Cipolla CM. Cardiotoxicity of Anthracyclines. Front Cardiovasc Med. 2020 Mar 18;7:26. doi: 10.3389/fcvm.2020.00026. eCollection 2020.
- Background: PubMed 26834065Armenian SH, Xu L, Ky B, Sun C, Farol LT, Pal SK, Douglas PS, Bhatia S, Chao C. Cardiovascular Disease Among Survivors of Adult-Onset Cancer: A Community-Based Retrospective Cohort Study. J Clin Oncol. 2016 Apr 1;34(10):1122-30. doi: 10.1200/JCO.2015.64.0409. Epub 2016 Feb 1.
- Background: PubMed 27732702Abdel-Qadir H, Austin PC, Lee DS, Amir E, Tu JV, Thavendiranathan P, Fung K, Anderson GM. A Population-Based Study of Cardiovascular Mortality Following Early-Stage Breast Cancer. JAMA Cardiol. 2017 Jan 1;2(1):88-93. doi: 10.1001/jamacardio.2016.3841.
- Background: PubMed 25948538Cardinale D, Colombo A, Bacchiani G, Tedeschi I, Meroni CA, Veglia F, Civelli M, Lamantia G, Colombo N, Curigliano G, Fiorentini C, Cipolla CM. Early detection of anthracycline cardiotoxicity and improvement with heart failure therapy. Circulation. 2015 Jun 2;131(22):1981-8. doi: 10.1161/CIRCULATIONAHA.114.013777. Epub 2015 May 6.
- Figures of cancer incidence, prevalence, mortality, survival and risk factors in SpainLink provided by the sponsor.
- Individual participant dataSharing planned: No. The information will be shared with the patients after the completion of every test. This information will be shared only with the participant researchers of this study.
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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.
Soraya Casla-Barrio, PhD principal investigator
Tigers Running Club
Helios Pareja-Galeano, PhD study chair
Universidad Autonoma de Madrid
Mónica Castellanos, MSc study chair
Tigers Running Club
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncological physical exercise intervention and Active Physical Activities intervention in people with Breast Cancer and Cancer Survivors, run by Tigers Running Club at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 18 Dec 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiovascular fitness (time frame: 16 weeks). 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 NCT05882578, which also lists 24 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 18 Dec 2024.