Cancer Therapy-Related Cardiac DysfunctionCARPTOX-BCNCT06881940
Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Treatment With Anthracyclines and/or Trastuzumab
A study testing Rehabilitation Program and No Rehabilitation Program in people with Cancer Therapy-Related Cardiac Dysfunction, run by Instituto Nacional de Cardiologia Ignacio Chavez at 2 sites in Mexico.
Trial summary
This study aims to evaluate the effectiveness of a cardiac rehabilitation protocol, incorporating aerobic and resistance exercise, in reducing the incidence of cardiotoxicity in breast cancer patients receiving treatment with anthracyclines and/or trastuzumab through a randomized, active control group, open-label… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cancer Therapy-Related Cardiac Dysfunction
- What is being tested?
- Rehabilitation Program and No Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Apr 2025to 1 Dec 2029
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 18 and 70 years will be considered eligible.
- Active residents of any municipality within Mexico City and the surrounding metropolitan area will qualify, conditioned that their maximum travel time from their residence to our recruitment center does not exceed three hours using private or public transportation. This criterion is established to ensure adherence to the protocol and availability for participation in the required interventions and assessments throughout the study.
- Patients diagnosed with early-stage or locally advanced breast cancer (stages I, II, or III, according to the TNM classification-Tumor, Node, Metastasis) who will undergo treatment with anthracyclines and/or adjuvant/neoadjuvant anti-HER2 therapy will be included. Participants must be scheduled to receive pharmacological treatment, ensuring that the study focuses on a population undergoing specific therapies for breast cancer management.
- Candidates must have the capacity, availability, and willingness to participate in an aerobic and resistance exercise program. Participants are required to possess both the physical ability and the willingness to actively engage in a structured exercise program, which includes aerobic and resistance activities essential to the study's objectives.
- Patients will provide informed written consent to participate in the study. To uphold ethical research principles and ensure the protection of participants' rights, all patients must voluntarily give their informed consent after receiving comprehensive information regarding the study's objectives, procedures, benefits, and potential risks.
Who cannot join
- Metastatic disease: Individuals with medical or imaging evidence of metastasis to any peripheral organ.
- Cardiovascular disease: Patients with a self-reported history of cardiovascular conditions, such as heart failure or uncontrolled hypertension, that may limit their ability to safely engage in physical activity. Additionally, those with peripheral arterial disease or valvular heart disease will not be eligible.
- Ischemic heart disease: Patients with a history of ischemic heart disease.
- Neurological disorders: Individuals with self-reported neurological diseases that significantly impair coordination, balance, or motor control, such as advanced Parkinson's disease, late-stage multiple sclerosis, or paralysis, making physical activity unsafe.
- Musculoskeletal conditions: Patients with self-reported musculoskeletal injuries or disorders that hinder physical activity, including fractures within the last five years, moderate to severe sprains, tendinitis, or severe arthritis.
- Uncontrolled systemic comorbidities: Individuals with decompensated systemic conditions, including heart failure, chronic kidney disease, or poorly controlled diabetes, will be excluded.
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- Severe respiratory diseases: Patients with severe respiratory conditions that prevent physical exercise participation.
- Physical limitations: Individuals with mobility impairments or conditions requiring constant assistance for basic physical activities, such as those using assistive devices (e.g., wheelchairs, walkers) or with limb amputations, will not be eligible for participation.
- Severe psychiatric disorders: Patients with uncontrolled psychiatric conditions, including schizophrenia, severe bipolar disorder, or major depressive disorder, that may interfere with their ability to actively participate in a supervised exercise program.
- Elimination Criteria:
- Voluntary withdrawal from the protocol.
- Development of severe cardiotoxicity requiring pharmacological treatment.
- Adverse reactions to chemotherapeutic agents.
- Disease progression according to the TNM classification during treatment.
- Failure to complete at least 80% of the prescribed adjuvant or neoadjuvant oncological treatment.
- Occurrence of adverse events during the study, such as falls or injuries.
- Death during the study period.
- Any accident related to the exercise protocol, including falls, sprains, or fractures.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Neftali Eduardo Antonio-Villa, M.D., Ph.D contact
Mexico2 sites
Instituto Nacional de Cancerología (INCAN)
Mexico City, Mexico City, 14080
Arely Velazquez Martínez, M.D, 55 5628 0400, arevlm.1210@gmail.com
Nilda Espinola-Zavaleta, M.D, Ph.D, +525555732911 ext. 21001, niesza2001@hotmail.com
National Institute of Cancerology (INCAN)
Mexico City, Mexico City, 14080
About this study
Official title: Rationale and Design of a Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Treatment With Anthracyclines and/or Trastuzumab: A Randomized, Active Control Group, Open-Label Trial
This study aims to evaluate the effectiveness of a cardiac rehabilitation protocol, incorporating aerobic and resistance exercise, in reducing the incidence of cardiotoxicity in breast cancer patients receiving treatment with anthracyclines and/or trastuzumab through a randomized, active control group, open-label clinical trial.
Read the detailed description
This is a randomized, open-label, with an active control group trial. This study adopts the main evaluation indicator being the incidence of cardiac dysfunction or heart failure as a manifestation of cardiovascular toxicity, assessed following the 2022 European Society of Cardiology (ESC) definitions for cancer-related therapy cardiac dysfunction (CTRCD).
Participants who pass the inclusion criteria through research will provide written informed consent to take part in the study. Once consent is obtained, participants will be randomly assigned to one of two study groups using a simple randomization process. This will be accomplished through a computer-generated random number sequence list, which will be managed by a designated investigator from the research team. The intervention group will receive standard oncological treatment combined with an aerobic and resistance exercise program, following the FITT principle (Frequency, Intensity, Type, and Time) for exercise prescription. Three out of five weekly sessions will be conducted per week. The control group will continue standard oncological treatment in addition to general recommendations regarding diet and physical activity but without a structured exercise protocol. During the treatment process, both branches of the trial will be followed over a 12 months period, with scheduled outpatient evaluations to assess biochemical parameters, a 12-lead electrocardiogram (ECG), a transthoracic echocardiogram (TTE), and a cardiopulmonary exercise test (CPET). Both the intervention and control groups will undergo these assessments at four key time points: baseline (defined as the time before the start of the chemotherapy regime and after the study enrollment), 3 months, 6 months, and 12 months post-initiation of chemotherapy. The main outcome of this clinical trial is a composite of incident cardiotoxicity, defined according to the ESC guidelines. Other cardiac function related indicators such as symptomatic congestive heart failure or asymptomatic but decreased left ventricular ejection fraction (LVEF) or global longitudinal strain (GLS) and changes in cardiac biomarkers will be evaluated to determine the occurrence of cardiac toxicity. Secondary outcomes assessed the impact on echocardiographic parameters of cardiac function, fluctuations in biomarkers and blood tests, cardiorespiratory performance, the impact of quality of life and explore the role of traditional cardiovascular risk factors.
- Being tested
- Rehabilitation Program, No Rehabilitation Program
- Keywords
- Rehabilitation, Breast Neoplasms, Cardiotoxicity, Trastuzumab, Anthracyclines
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation ProgramOther
Three of the five weekly sessions will take place at the gym in the Functional Unit of Breast Tumors at INCAN, under the supervision of Physical and Sports Medicine specialists and three physical therapists. These sessions allow for personalized feedback, enabling participants to confidently perform prescribed aerobic exercises at home on the remaining two days.
Each session starts with a 10- to 15-minute warm-up focused on joint mobility. Aerobic training is conducted at moderate intensity (40-59% VO2max or heart rate reserve), monitored with a Polar® FT1 device. Intensity is periodically adjusted based on the Borg Rating of Perceived Exertion and the talk test. Over 4-6 weeks, session duration will gradually increase to 90 minutes per week, remaining consistent thereafter.
Following aerobic training, resistance exercises targeting major muscle groups are performed using gym machines and dumbbells. The program includes seven exercises, progressively increasing load over 3-4 weeks.
No Rehabilitation ProgramOther
The control group will continue standard oncological treatment in addition to general recommendations regarding diet and physical activity, but without a structured exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Participants randomized to observational arm will receive standard oncological follow up and care. Receives: Other: No Rehabilitation Program |
| Rehabilitation Program | Experimental | Intervention arm receives standard oncological follow up and care + Rehabilitation Program Receives: Other: Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cardiac dysfunction or heart failure as a manifestation of cardiovascular toxicity in the intervention group and control group
Calculate the incidence of cardiotoxicity associated with anthracycline and/or trastuzumab treatment of two groups following the 2022 European Society of Cardiology (ESC) definitions for cancer-related therapy cardiac dysfunction (CTRCD). LVEF greater than 50% with a relative GLS decrease exceeding 15% and/or a new rise in cardiac biomarkers. LVEF will be determined using Simpson's biplane method, incorporating apical four- and two-chamber views, while 2D-GLS measurements will be performed via velocity vector imaging. All echocardiographic evaluations will be conducted using a Siemens-Acuson 2000 system by a single expert in echocardiography, with results subsequently verified by a second expert to ensure accuracy and reliability. The classification of symptomatic congestive heart failure encompasses, but is not limited to, the presence of one or more of the following clinical manifestations: moist crackles in the lungs, bilateral anterior tibial edema, or lip cyanosis.
Measured: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Secondary outcomes (5)
Impact on echocardiographic parameters
This study aims to evaluate cardiac function by examining changes in echocardiographic parameters, including chamber volumes, diameters, diastolic function, right ventricular function, and both biventricular and auricular global longitudinal strain (GLS).
Measured: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Modification in series of circulating cardiac biomarkers
Classical biomarkers of cardiac injury: C-reactive protein, Troponin I, B-type natriuretic peptide (NT-Pro BNP).
Measured: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Evaluation of cardiorespiratory performance
The study will investigate modifications in cardiorespiratory fitness by measuring peak oxygen uptake (VO2max) through a cardiopulmonary exercise test (CPET) conducted on a bicycle ergometer with individualized workload adjustments.
Measured: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Quality of Life Questionnaire: FACT-B
Investigators should evaluate the quality of life of the patient with QOL questionnaire (FACT-B)
Measured: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Explore the role of traditional cardiovascular risk factors
This research will explore the role of conventional cardiovascular risk factors-including smoking, lipid levels, systemic arterial hypertension, diabetes, obesity, sedentary behavior, and the Framingham risk score-as potential mediators in the development of cardiotoxicity.
Measured: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cancer Therapy-Related Cardiac DysfunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional Model: Active Control Group Interventional Model Description: The risk exposure factors for the experimental group and the control group are the same Masking: None (Open Label) Allocation: Randomized
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cancerologia de Mexico
- Responsible party
- Principal investigator, Nilda Gladys Espinola Zavaleta, Instituto Nacional de Cardiologia Ignacio Chavez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881940
- Sponsor's protocol ID
- 24-1488
- Acronym
- CARPTOX-BC
- Status last verified
- Dec 2024
- First submitted
- 5 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Can apply to researchers
Publications
Kerrigan DJ, Reddy M, Walker EM, Cook B, McCord J, Loutfi R, Saval MA, Baxter J, Brawner CA, Keteyian SJ. Cardiac Rehabilitation Improves Fitness in Patients With Subclinical Markers of Cardiotoxicity While Receiving Chemotherapy: A RANDOMIZED CONTROLLED STUDY. J Cardiopulm Rehabil Prev. 2023 Mar 1;43(2):129-134. doi: 10.1097/HCR.0000000000000719. Epub 2022 Aug 4.
PubMed 35940850Viamonte SG, Joaquim AV, Alves AJ, Vilela E, Capela A, Ferreira C, Duarte BF, Rato ND, Teixeira MP, Tavares A, Santos M, Ribeiro F. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2023 Dec 1;8(12):1119-1128. doi: 10.1001/jamacardio.2023.3558.
PubMed 37819656Diaz-Balboa E, Pena-Gil C, Rodriguez-Romero B, Cuesta-Vargas AI, Lado-Baleato O, Martinez-Monzonis A, Pedreira-Perez M, Palacios-Ozores P, Lopez-Lopez R, Gonzalez-Juanatey JR, Gonzalez-Salvado V. Exercise-based cardio-oncology rehabilitation for cardiotoxicity prevention during breast cancer chemotherapy: The ONCORE randomized controlled trial. Prog Cardiovasc Dis. 2024 Jul-Aug;85:74-81. doi: 10.1016/j.pcad.2024.02.002. Epub 2024 Feb 21.
PubMed 38395212Yang HL, Hsieh PL, Hung CH, Cheng HC, Chou WC, Chu PM, Chang YC, Tsai KL. Early Moderate Intensity Aerobic Exercise Intervention Prevents Doxorubicin-Caused Cardiac Dysfunction Through Inhibition of Cardiac Fibrosis and Inflammation. Cancers (Basel). 2020 Apr 28;12(5):1102. doi: 10.3390/cancers12051102.
PubMed 32354131Kouzi SA, Uddin MN. Aerobic Exercise Training as a Potential Cardioprotective Strategy to Attenuate Doxorubicin-Induced Cardiotoxicity. J Pharm Pharm Sci. 2016 Jul-Sep;19(3):399-410. doi: 10.18433/J3JS5R.
PubMed 27806245Yu AF, Jones LW. Breast cancer treatment-associated cardiovascular toxicity and effects of exercise countermeasures. Cardiooncology. 2016;2:1. doi: 10.1186/s40959-016-0011-5. Epub 2016 Feb 25.
PubMed 28133540Xie S, Sun Y, Zhao X, Xiao Y, Zhou F, Lin L, Wang W, Lin B, Wang Z, Fang Z, Wang L, Zhang Y. An update of the molecular mechanisms underlying anthracycline induced cardiotoxicity. Front Pharmacol. 2024 Jun 26;15:1406247. doi: 10.3389/fphar.2024.1406247. eCollection 2024.
PubMed 38989148Nebigil CG, Desaubry L. Updates in Anthracycline-Mediated Cardiotoxicity. Front Pharmacol. 2018 Nov 12;9:1262. doi: 10.3389/fphar.2018.01262. eCollection 2018.
PubMed 30483123Angsutararux P, Luanpitpong S, Issaragrisil S. Chemotherapy-Induced Cardiotoxicity: Overview of the Roles of Oxidative Stress. Oxid Med Cell Longev. 2015;2015:795602. doi: 10.1155/2015/795602. Epub 2015 Sep 29.
PubMed 26491536Herrmann J, Lenihan D, Armenian S, Barac A, Blaes A, Cardinale D, Carver J, Dent S, Ky B, Lyon AR, Lopez-Fernandez T, Fradley MG, Ganatra S, Curigliano G, Mitchell JD, Minotti G, Lang NN, Liu JE, Neilan TG, Nohria A, O'Quinn R, Pusic I, Porter C, Reynolds KL, Ruddy KJ, Thavendiranathan P, Valent P. Defining cardiovascular toxicities of cancer therapies: an International Cardio-Oncology Society (IC-OS) consensus statement. Eur Heart J. 2022 Jan 31;43(4):280-299. doi: 10.1093/eurheartj/ehab674.
PubMed 34904661Wang Y, Wang Y, Han X, Sun J, Li C, Adhikari BK, Zhang J, Miao X, Chen Z. Cardio-Oncology: A Myriad of Relationships Between Cardiovascular Disease and Cancer. Front Cardiovasc Med. 2022 Mar 17;9:727487. doi: 10.3389/fcvm.2022.727487. eCollection 2022.
PubMed 35369296Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
PubMed 31626055Gilchrist SC, Barac A, Ades PA, Alfano CM, Franklin BA, Jones LW, La Gerche A, Ligibel JA, Lopez G, Madan K, Oeffinger KC, Salamone J, Scott JM, Squires RW, Thomas RJ, Treat-Jacobson DJ, Wright JS; American Heart Association Exercise, Cardiac Rehabilitation, and Secondary Prevention Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Council on Peripheral Vascular Disease. Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. Circulation. 2019 May 21;139(21):e997-e1012. doi: 10.1161/CIR.0000000000000679.
PubMed 30955352Lavin-Perez AM, Collado-Mateo D, Hinojo Gonzalez C, de Juan Ferre A, Ruisanchez Villar C, Mayo X, Jimenez A. High-intensity exercise prescription guided by heart rate variability in breast cancer patients: a study protocol for a randomized controlled trial. BMC Sports Sci Med Rehabil. 2023 Mar 8;15(1):28. doi: 10.1186/s13102-023-00634-2.
PubMed 36890601
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rationale and Design of a Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Treatment With Anthracyclines and/or Trastuzumab: A Randomized, Active Control Group, Open-Label Trial
- ClinicalTrials.gov ID
- NCT06881940
- Acronym / sponsor ID
- CARPTOX-BC / 24-1488
- Keywords
- Rehabilitation, Breast Neoplasms, Cardiotoxicity, Trastuzumab, Anthracyclines
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cancerologia de Mexico
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 18 Mar 2025 (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.
This study aims to evaluate the effectiveness of a cardiac rehabilitation protocol, incorporating aerobic and resistance exercise, in reducing the incidence of cardiotoxicity in breast cancer patients receiving treatment with anthracyclines and/or trastuzumab through a randomized, active control group, open-label clinical trial.
Detailed description
This is a randomized, open-label, with an active control group trial. This study adopts the main evaluation indicator being the incidence of cardiac dysfunction or heart failure as a manifestation of cardiovascular toxicity, assessed following the 2022 European Society of Cardiology (ESC) definitions for cancer-related therapy cardiac dysfunction (CTRCD).
Participants who pass the inclusion criteria through research will provide written informed consent to take part in the study. Once consent is obtained, participants will be randomly assigned to one of two study groups using a simple randomization process. This will be accomplished through a computer-generated random number sequence list, which will be managed by a designated investigator from the research team. The intervention group will receive standard oncological treatment combined with an aerobic and resistance exercise program, following the FITT principle (Frequency, Intensity, Type, and Time) for exercise prescription. Three out of five weekly sessions will be conducted per week. The control group will continue standard oncological treatment in addition to general recommendations regarding diet and physical activity but without a structured exercise protocol. During the treatment process, both branches of the trial will be followed over a 12 months period, with scheduled outpatient evaluations to assess biochemical parameters, a 12-lead electrocardiogram (ECG), a transthoracic echocardiogram (TTE), and a cardiopulmonary exercise test (CPET). Both the intervention and control groups will undergo these assessments at four key time points: baseline (defined as the time before the start of the chemotherapy regime and after the study enrollment), 3 months, 6 months, and 12 months post-initiation of chemotherapy. The main outcome of this clinical trial is a composite of incident cardiotoxicity, defined according to the ESC guidelines. Other cardiac function related indicators such as symptomatic congestive heart failure or asymptomatic but decreased left ventricular ejection fraction (LVEF) or global longitudinal strain (GLS) and changes in cardiac biomarkers will be evaluated to determine the occurrence of cardiac toxicity. Secondary outcomes assessed the impact on echocardiographic parameters of cardiac function, fluctuations in biomarkers and blood tests, cardiorespiratory performance, the impact of quality of life and explore the role of traditional cardiovascular risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional Model: Active Control Group Interventional Model Description: The risk exposure factors for the experimental group and the control group are the same Masking: None (Open Label) Allocation: Randomized
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: No Rehabilitation ProgramParticipants randomized to observational arm will receive standard oncological follow up and care. |
| Rehabilitation Program | Experimental | Other: Rehabilitation ProgramIntervention arm receives standard oncological follow up and care + Rehabilitation Program |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged between 18 and 70 years will be considered eligible.
- Active residents of any municipality within Mexico City and the surrounding metropolitan area will qualify, conditioned that their maximum travel time from their residence to our recruitment center does not exceed three hours using private or public transportation. This criterion is established to ensure adherence to the protocol and availability for participation in the required interventions and assessments throughout the study.
- Patients diagnosed with early-stage or locally advanced breast cancer (stages I, II, or III, according to the TNM classification-Tumor, Node, Metastasis) who will undergo treatment with anthracyclines and/or adjuvant/neoadjuvant anti-HER2 therapy will be included. Participants must be scheduled to receive pharmacological treatment, ensuring that the study focuses on a population undergoing specific therapies for breast cancer management.
- Candidates must have the capacity, availability, and willingness to participate in an aerobic and resistance exercise program. Participants are required to possess both the physical ability and the willingness to actively engage in a structured exercise program, which includes aerobic and resistance activities essential to the study's objectives.
- Patients will provide informed written consent to participate in the study. To uphold ethical research principles and ensure the protection of participants' rights, all patients must voluntarily give their informed consent after receiving comprehensive information regarding the study's objectives, procedures, benefits, and potential risks.
Key exclusion criteria (18 listed)
- Metastatic disease: Individuals with medical or imaging evidence of metastasis to any peripheral organ.
- Cardiovascular disease: Patients with a self-reported history of cardiovascular conditions, such as heart failure or uncontrolled hypertension, that may limit their ability to safely engage in physical activity. Additionally, those with peripheral arterial disease or valvular heart disease will not be eligible.
- Ischemic heart disease: Patients with a history of ischemic heart disease.
- Neurological disorders: Individuals with self-reported neurological diseases that significantly impair coordination, balance, or motor control, such as advanced Parkinson's disease, late-stage multiple sclerosis, or paralysis, making physical activity unsafe.
- Musculoskeletal conditions: Patients with self-reported musculoskeletal injuries or disorders that hinder physical activity, including fractures within the last five years, moderate to severe sprains, tendinitis, or severe arthritis.
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 |
|---|---|---|
| Rehabilitation ProgramThree of the five weekly sessions will take place at the gym in the Functional Unit of Breast Tumors at INCAN, under the supervision of Physical and Sports Medicine specialists and three physical therapists. These sessions allow for personalized feedback, enabling participants to confidently perform prescribed aerobic exercises at home on the remaining two days. Each session starts with a 10- to 15-minute warm-up focused on joint mobility. Aerobic training is conducted at moderate intensity (40-59% VO2max or heart rate reserve), monitored with a Polar® FT1 device. Intensity is periodically adjusted based on the Borg Rating of Perceived Exertion and the talk test. Over 4-6 weeks, session duration will gradually increase to 90 minutes per week, remaining consistent thereafter. Following aerobic training, resistance exercises targeting major muscle groups are performed using gym machines and dumbbells. The program includes seven exercises, progressively increasing load over 3-4 weeks. | Other | Rehabilitation Program |
| No Rehabilitation ProgramThe control group will continue standard oncological treatment in addition to general recommendations regarding diet and physical activity, but without a structured exercise protocol. | Other | Standard of care |
Primary outcome
Incidence of cardiac dysfunction or heart failure as a manifestation of cardiovascular toxicity in the intervention group and control group
Time frame: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Calculate the incidence of cardiotoxicity associated with anthracycline and/or trastuzumab treatment of two groups following the 2022 European Society of Cardiology (ESC) definitions for cancer-related therapy cardiac dysfunction (CTRCD). LVEF greater than 50% with a relative GLS decrease exceeding 15% and/or a new rise in cardiac biomarkers. LVEF will be determined using Simpson's biplane method, incorporating apical four- and two-chamber views, while 2D-GLS measurements will be performed via velocity vector imaging. All echocardiographic evaluations will be conducted using a Siemens-Acuson 2000 system by a single expert in echocardiography, with results subsequently verified by a second expert to ensure accuracy and reliability. The classification of symptomatic congestive heart failure encompasses, but is not limited to, the presence of one or more of the following clinical manifestations: moist crackles in the lungs, bilateral anterior tibial edema, or lip cyanosis.
5 secondary outcomes
Impact on echocardiographic parameters
Time frame: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Modification in series of circulating cardiac biomarkers
Time frame: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Evaluation of cardiorespiratory performance
Time frame: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Quality of Life Questionnaire: FACT-B
Time frame: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
Explore the role of traditional cardiovascular risk factors
Time frame: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen
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 18 Mar 2025.
- Background: PubMed 35940850Kerrigan DJ, Reddy M, Walker EM, Cook B, McCord J, Loutfi R, Saval MA, Baxter J, Brawner CA, Keteyian SJ. Cardiac Rehabilitation Improves Fitness in Patients With Subclinical Markers of Cardiotoxicity While Receiving Chemotherapy: A RANDOMIZED CONTROLLED STUDY. J Cardiopulm Rehabil Prev. 2023 Mar 1;43(2):129-134. doi: 10.1097/HCR.0000000000000719. Epub 2022 Aug 4.
- Background: PubMed 37819656Viamonte SG, Joaquim AV, Alves AJ, Vilela E, Capela A, Ferreira C, Duarte BF, Rato ND, Teixeira MP, Tavares A, Santos M, Ribeiro F. Cardio-Oncology Rehabilitation for Cancer Survivors With High Cardiovascular Risk: A Randomized Clinical Trial. JAMA Cardiol. 2023 Dec 1;8(12):1119-1128. doi: 10.1001/jamacardio.2023.3558.
- Background: PubMed 38395212Diaz-Balboa E, Pena-Gil C, Rodriguez-Romero B, Cuesta-Vargas AI, Lado-Baleato O, Martinez-Monzonis A, Pedreira-Perez M, Palacios-Ozores P, Lopez-Lopez R, Gonzalez-Juanatey JR, Gonzalez-Salvado V. Exercise-based cardio-oncology rehabilitation for cardiotoxicity prevention during breast cancer chemotherapy: The ONCORE randomized controlled trial. Prog Cardiovasc Dis. 2024 Jul-Aug;85:74-81. doi: 10.1016/j.pcad.2024.02.002. Epub 2024 Feb 21.
- Background: PubMed 32354131Yang HL, Hsieh PL, Hung CH, Cheng HC, Chou WC, Chu PM, Chang YC, Tsai KL. Early Moderate Intensity Aerobic Exercise Intervention Prevents Doxorubicin-Caused Cardiac Dysfunction Through Inhibition of Cardiac Fibrosis and Inflammation. Cancers (Basel). 2020 Apr 28;12(5):1102. doi: 10.3390/cancers12051102.
- Background: PubMed 27806245Kouzi SA, Uddin MN. Aerobic Exercise Training as a Potential Cardioprotective Strategy to Attenuate Doxorubicin-Induced Cardiotoxicity. J Pharm Pharm Sci. 2016 Jul-Sep;19(3):399-410. doi: 10.18433/J3JS5R.
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- Individual participant dataSharing planned: No. Can apply to researchers
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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.
Neftali Eduardo Antonio-Villa, M.D., Ph.D contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Program and No Rehabilitation Program in people with Cancer Therapy-Related Cardiac Dysfunction, run by Instituto Nacional de Cardiologia Ignacio Chavez at 2 sites in Mexico.
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 18 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: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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 Nilda G. Espinola-Zavaleta, M.D., Ph.D (+525555732911 ext. 21001, niesza2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiac dysfunction or heart failure as a manifestation of cardiovascular toxicity in the intervention group and control group (time frame: From 1 week before starting oncological treatment to 1 year after the start of the chemotherapy regimen). 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 NCT06881940, which also lists 26 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 Mar 2025.