Cardiac AbnormalitiesCancerNCT07640087
Effects Of Physical Training On Cardiovascular Capacity In Patients Undergoing Chemotherapy For Cancer
A study testing physical training in people with Cardiac Abnormalities and Chemotherapeutic Toxicity, run by Federal University of Maranhao.
Trial summary
Introduction: Cancer treatment, especially chemotherapy and radiotherapy, can lead to cardiovascular dysfunctions, such as a decrease in left ventricular ejection fraction and electrical dysfunction of the heart, which may consequently compromise patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Cardiac Abnormalities, Chemotherapeutic Toxicity
- What is being tested?
- physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2026to 1 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a confirmed diagnosis of cancer who are undergoing chemotherapy treatment with anthracyclines;
- No physical exercise intervention for the past 3 months;
- Patients in the early or intermediate stages of cancer treatment;
- Adult patients (e.g., 18 to 59 years old) to avoid extreme variations in response to physical exercise;
- Clinically stable patients, without absolute contraindications to physical exercise (e.g., decompensated heart failure, severe arrhythmias);
- Patients able to participate in a supervised physical exercise program during the study period
Who cannot join
- Patients with severe pre-existing cardiac conditions (e.g., advanced cardiomyopathy, unstable angina) that prevent safe exercise practice;
- Patients with physical (e.g., inability to walk) or cognitive limitations that prevent participation in the physical exercise program;
- Patients undergoing treatments that may interfere with the results (e.g., recent thoracic radiotherapy, use of cardiotoxic agents unrelated to the study);
- Patients who already engage in regular and intense physical exercise, as this could interfere with the effects of the intervention.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Introduction: Cancer treatment, especially chemotherapy and radiotherapy, can lead to cardiovascular dysfunctions, such as a decrease in left ventricular ejection fraction and electrical dysfunction of the heart, which may consequently compromise patients' quality of life. In this context, physical exercise is a beneficial and promising tool, as it can prevent and minimize the deleterious effects of oncological therapies and their complications.
Objective: To evaluate the effect of physical exercise on the prevention of cardiovascular diseases (CVD) induced by cancer treatment, analyzing the impact of supervised exercise on cardiovascular function and quality of life.
Read more
Materials and Methods: This is a clinical trial in which the sample will consist of 60 individuals undergoing cancer treatment, who will be stratified and randomized according to cancer stage classification into two groups: Intervention Group (IG) and Control Group (CG). The intervention will last 12 weeks, during which the IG will receive a prescription for physical exercises based on the FITT principle (frequency, intensity, time, and type), three times per week, while the CG will remain under usual care. Data will be presented using descriptive statistics, tests for two independent samples, and multivariate analysis, comparing the intervention effects between the two groups using R software version 4.3.3.
Expected Results: Low incidence of CVD, improved heart rate variability, adherence to the exercise protocol, reduced risk for cardiovascular diseases, improvement in fatigue, functional capacity, and quality of life. Data will be collected at baseline, at the 6th week, and at the 12th week of intervention.
Read the detailed description
Cancer is a disease characterized by the uncontrolled growth of abnormal cells that invade organs and tissues. It is one of the leading causes of mortality worldwide, with high incidence and prevalence. Despite the progress in cancer treatment, it can generate a range of side effects and increase the risk of developing other diseases.
Cardio-oncology has become an area of great importance in research and presents a bidirectional relationship, as it links cardiovascular diseases to the risk of developing cancer and vice versa. It also focuses on the early diagnosis of CVD in patients undergoing cancer treatment. Cardio-oncology investigates and identifies factors that may cause cardiac damage, compromising the heart's structure and function, and relates these factors to the chemotherapy used.
One of the complications of chemotherapy is anthracycline-induced cardiotoxicity, which leads to increased expression of cellular senescence and adverse effects on the heart, including ventricular dysfunction, arrhythmias, myocardial fibrosis, and heart failure. These effects are dose-dependent and may be irreversible.
In this context, it is essential to adopt strategies that mitigate the impact of cardiotoxicity, improving prognosis and the quality of life of patients undergoing cancer treatment. Studies have shown that physical exercise has positive effects on quality of life, autonomic function, cardiopulmonary function, strength, and functional capacity during the phases of anticancer therapy.
Given this scenario, this study is justified by the emerging need for knowledge about the benefits of physical training on cardiovascular capacity, contributing to the elucidation of clinical practice, effective decision-making, and better management of this population.
- Conditions
- Cardiac Abnormalities, Chemotherapeutic Toxicity
- Being tested
- physical training
- Keywords
- QUALITY OF LIFE, PAIN, EXERCISE
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical trainingOther
Also called exercicio fisico, physical training, competing group
The concurrent physical training program will last 12 weeks and will consist of aerobic and resistance exercises.The physical exercises for aerobic training will consist of walking and/or cycling on a stationary bike, performed 3 times a week with progressive intensity.Strength training exercises for upper (UL) and lower (LL) limbs will be performed using dumbbells, ankle weights, resistance bands, and body weight for patients undergoing chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: will undergo routine monitoring and evaluation, without exercise intervention. | No intervention | Patients who will not participate in physical exercise programs, but will be monitored under the same clinical and monitoring conditions. |
| physical training | Experimental | patients undergoing chemotherapy treatment who will perform physical exercise. Receives: Other: physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity
The biomarkers used for cardiovascular assessment of cancer patients are: ultrasensitive troponin I or T (marker of myocardial injury).
Measured: From registration to the end of treatment in 12 weeks
Heart rate variability
Heart rate variability (HRV) will be measured using a Vantage V3 Polar® heart rate monitor that measures the electrical activity of the heart.
Measured: From registration to the end of treatment in 12 weeks
Cardiovascular risk in cancer patients.
Cardiovascular risk will be assessed using the Framingham Scale, which measures the risk of cardiovascular disease in individuals through blood pressure, lipid profile (LDL and HDL), smoking, and diabetes, based on this data, which will be collected from patients' medical records.
Measured: From registration to the end of treatment in 12 weeks
Secondary outcomes (6)
Fatigue
Fatigue is a relevant symptom for cancer patients, with a greater impact than in the general population. It is a symptom described at all stages of the oncology patient's journey, presenting as physical, emotional, or cognitive exhaustion or weakness, which can interfere with daily function and chemotherapy treatment.
Measured: From registration to the end of treatment in 12 weeks
pain assessment
Pain assessment will be measured using the Brief Pain Inventory (BPI), a 10-point pain intensity scale.
Pain is a primary symptom among cancer patients and cancer survivors. Integrative interventions, such as acupuncture, massage, and music therapy, are effective non-pharmacological approaches for oncological pain with low cost and minimal adverse events
Measured: From registration to the end of treatment in 12 weeks
Quality of life Global
The instrument used to assess Quality of life global for cancer will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-BR). The higher scores mean a worse quality of life and lower scores mean a better quality of life.
Measured: From registration to the end of treatment in 12 weeks
Body Composition
Body composition will be assessed using bioimpedance. Cancer leads to metabolic changes that contribute to depletion of nutritional status, resulting in alterations in body composition.
Measured: From registration to the end of treatment in 12 weeks
functional capacity
Functional capacity will be assessed by the 6-minute walk test (6MWT) performed in a 10m corridor. The 6MWT test will measure the total distance covered (meter). The greater the distance, the better the functional capacity.
Measured: From registration to the end of treatment in 12 weeks
adherence to physical exercise
Adherence will be determined through the patients' weekly attendance, and will be monitored by the researcher.
Measured: From registration to the end of treatment in 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start5 Aug 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AbnormalitiesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Maranhao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréa Dias Reis, Federal University of Maranhao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640087
- Sponsor's protocol ID
- 88362125200005087
- Other IDs
- CAAE:88362125200005087
- Acronym
- Cancer
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Physical Training On Cardiovascular Capacity In Patients Undergoing Chemotherapy For Cancer
- ClinicalTrials.gov ID
- NCT07640087
- Acronym / sponsor ID
- Cancer / 88362125200005087
- Conditions
- Cardiac Abnormalities, Chemotherapeutic Toxicity
- Keywords
- QUALITY OF LIFE, PAIN, EXERCISE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of MaranhaoUniversity, hospital or other
- Study start
- 5 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Jun 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.
Introduction: Cancer treatment, especially chemotherapy and radiotherapy, can lead to cardiovascular dysfunctions, such as a decrease in left ventricular ejection fraction and electrical dysfunction of the heart, which may consequently compromise patients' quality of life. In this context, physical exercise is a beneficial and promising tool, as it can prevent and minimize the deleterious effects of oncological therapies and their complications.
Objective: To evaluate the effect of physical exercise on the prevention of cardiovascular diseases (CVD) induced by cancer treatment, analyzing the impact of supervised exercise on cardiovascular function and quality of life.
Materials and Methods: This is a clinical trial in which the sample will consist of 60 individuals undergoing cancer treatment, who will be stratified and randomized according to cancer stage classification into two groups: Intervention Group (IG) and Control Group (CG). The intervention will last 12 weeks, during which the IG will receive a prescription for physical exercises based on the FITT principle (frequency, intensity, time, and type), three times per week, while the CG will remain under usual care. Data will be presented using descriptive statistics, tests for two independent samples, and multivariate analysis, comparing the intervention effects between the two groups using R software version 4.3.3.
Expected Results: Low incidence of CVD, improved heart rate variability, adherence to the exercise protocol, reduced risk for cardiovascular diseases, improvement in fatigue, functional capacity, and quality of life. Data will be collected at baseline, at the 6th week, and at the 12th week of intervention.
Detailed description
Cancer is a disease characterized by the uncontrolled growth of abnormal cells that invade organs and tissues. It is one of the leading causes of mortality worldwide, with high incidence and prevalence. Despite the progress in cancer treatment, it can generate a range of side effects and increase the risk of developing other diseases.
Cardio-oncology has become an area of great importance in research and presents a bidirectional relationship, as it links cardiovascular diseases to the risk of developing cancer and vice versa. It also focuses on the early diagnosis of CVD in patients undergoing cancer treatment. Cardio-oncology investigates and identifies factors that may cause cardiac damage, compromising the heart's structure and function, and relates these factors to the chemotherapy used.
One of the complications of chemotherapy is anthracycline-induced cardiotoxicity, which leads to increased expression of cellular senescence and adverse effects on the heart, including ventricular dysfunction, arrhythmias, myocardial fibrosis, and heart failure. These effects are dose-dependent and may be irreversible.
In this context, it is essential to adopt strategies that mitigate the impact of cardiotoxicity, improving prognosis and the quality of life of patients undergoing cancer treatment. Studies have shown that physical exercise has positive effects on quality of life, autonomic function, cardiopulmonary function, strength, and functional capacity during the phases of anticancer therapy.
Given this scenario, this study is justified by the emerging need for knowledge about the benefits of physical training on cardiovascular capacity, contributing to the elucidation of clinical practice, effective decision-making, and better management of this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: will undergo routine monitoring and evaluation, without exercise intervention. | No intervention | –Patients who will not participate in physical exercise programs, but will be monitored under the same clinical and monitoring conditions. |
| physical training | Experimental | Other: physical trainingpatients undergoing chemotherapy treatment who will perform physical exercise. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| physical trainingAlso: exercicio fisico, physical training, competing groupThe concurrent physical training program will last 12 weeks and will consist of aerobic and resistance exercises.The physical exercises for aerobic training will consist of walking and/or cycling on a stationary bike, performed 3 times a week with progressive intensity.Strength training exercises for upper (UL) and lower (LL) limbs will be performed using dumbbells, ankle weights, resistance bands, and body weight for patients undergoing chemotherapy. | Other | physical training |
Primary outcome
Cardiotoxicity
Time frame: From registration to the end of treatment in 12 weeks
The biomarkers used for cardiovascular assessment of cancer patients are: ultrasensitive troponin I or T (marker of myocardial injury).
Heart rate variability
Time frame: From registration to the end of treatment in 12 weeks
Heart rate variability (HRV) will be measured using a Vantage V3 Polar® heart rate monitor that measures the electrical activity of the heart.
Cardiovascular risk in cancer patients.
Time frame: From registration to the end of treatment in 12 weeks
Cardiovascular risk will be assessed using the Framingham Scale, which measures the risk of cardiovascular disease in individuals through blood pressure, lipid profile (LDL and HDL), smoking, and diabetes, based on this data, which will be collected from patients' medical records.
6 secondary outcomes
Fatigue
Time frame: From registration to the end of treatment in 12 weeks
pain assessment
Time frame: From registration to the end of treatment in 12 weeks
Quality of life Global
Time frame: From registration to the end of treatment in 12 weeks
Body Composition
Time frame: From registration to the end of treatment in 12 weeks
functional capacity
Time frame: From registration to the end of treatment in 12 weeks
adherence to physical exercise
Time frame: From registration to the end of treatment in 12 weeks
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 26 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing physical training in people with Cardiac Abnormalities and Chemotherapeutic Toxicity, run by Federal University of Maranhao.
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 6 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: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 ANDREA DIAS REIS A Teacher, PhD (+5598987220570, andrea.dr@ufma.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiotoxicity (time frame: From registration to the end of treatment in 12 weeks). The study lists 3 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 26 Jun 2026.