CardiotoxicityNCT06595316
Exercise for Ameliorating Chemotherapy Cardiotoxicity
A study testing Exercise intervention group in people with Cardiotoxicity, run by University of Hull.
Trial summary
Chemotherapy is a common treatment for breast cancer but can damage the heart and blood vessels. Exercise, such as cycling, may stop chemotherapy from damaging the heart and blood vessels. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cardiotoxicity
- What is being tested?
- Exercise intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 1 Dec 2025
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females between 18 to 75 years old.
- Confirmed early stage (I-III) ER+ HER2 - breast cancer diagnosis
- Undergoing adjuvant and neoadjuvant chemotherapy, consisting of epirubicin and cyclophosphamide (EC) followed by Docetaxel.
- No contraindications to engage in physical activity.
- Capable of giving informed consent.
- Patients able to understand and communicate in English language
Who cannot join
- Participants with cognitive disorders
- Cancer metastases
- Uncontrolled or serious illnesses that might hamper patients' capacity of exercising
Trial locations and contacts
No sites are listed yet.
John Saxton, PhD contact
About this study
Official title: A Randomized Controlled Feasibility Trial of a Vigorous Intensity Aerobic Exercise and Resistance Training Intervention for Mitigating Chemotherapy Cardiotoxicity in Breast Cancer Patients
Chemotherapy is a common treatment for breast cancer but can damage the heart and blood vessels. Exercise, such as cycling, may stop chemotherapy from damaging the heart and blood vessels. Before the effects of exercise on the heart and blood vessels can be fully determined in a large trial, a small trial must first be carried out to assess if exercise can be included safely and practically during chemotherapy treatment.
This study is designed so that a group of breast cancer patients will exercise during their chemotherapy treatment, whilst another group does not exercise. Participants will be breast cancer patients from the Queen's Centre for Oncology and Haematology at Castle Hill Hospital. Suitable patients will be identified and approached by their Consultant Clinical Oncologist. If patients decide to take part, they will be randomly placed into groups ('exercise' or 'usual care') before starting chemotherapy. The exercise group will exercise for 50-60 minutes 2days/week in the Cardiac Rehabilitation Gym at Castle Hill Hospital during their chemotherapy treatment. Exercise will be supervised, consisting of repeated 5-minute bouts of high intensity cycling plus strength training. The usual care group will be given their normal chemotherapy only (no exercise). Both groups will take part in tests before they begin chemotherapy treatment. Tests assess heart and blood vessel health, fitness, strength, fatigue, and quality of life. The same tests will happen again during the intervention, after the intervention and 3-months later. Participants will also have to complete questionnaires to give their opinion of the study. The main point of the study is to determine if the exercise and tests are received well by patients, if recruitment is good, and if patients comply/adhere. This will inform a larger study which will assess if exercise maintains heart and vessel health during chemotherapy treatment.
Read the detailed description
Exercise has been shown to have benefits within cardio-oncology settings and evidence supports the use of exercise as a cardioprotective method in breast cancer. Several studies demonstrate evidence for positive effects of aerobic and resistance exercise to improve or alleviate the usual effects of chemotherapy on the heart and blood vessels in breast cancer. Despite the existing evidence that shows promising outcomes regarding exercise interventions for breast cancer patients undergoing chemotherapy who are at risk of developing cardiotoxicity due to treatment there is still insufficient evidence for exercise to be prescribed to this population as an adjuvant instrument to reduce cardiotoxicity.
Through this study we aim to build on the evidence base with the purpose of encouraging practice towards this approach. However, before a large definitive randomized controlled trial (RCT) can be conducted, the first step is to assess the feasibility of a high intensity exercise intervention during chemotherapy for breast cancer. This will inform the design of a large RCT which will determine the cardio-protective effects of the exercise intervention.
As this is a feasibility study the main outcome is to find out the practicalities of delivering the proposed exercise intervention in a healthcare setting by collecting information regarding eligibility, recruitment rates, retention, adherence, fidelity, and adverse events.
Secondary outcome measures will provide information about cardiac function, cardiovascular toxicity and inflammation, electrical activity of the heart, vascular function, functional capacity, muscle strength, fatigue, quality of life, and finally experiences and perceptions of patients after participating in the intervention.
- Conditions
- Cardiotoxicity
- Being tested
- Exercise intervention group
- Keywords
- exercise, cardiotoxicity, exercise oncology, breast cancer
- Medical subject headings
- Cardiotoxicity, Motor Activity, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise intervention groupOther
Exercise will consist of two supervised sessions per week. Starting with vital signs monitoring (blood pressure, temperature, blood oxygen levels, heart rate).
The aerobic component consists of a 5-minute warm-up, followed by 3 bouts of 4-minute cycling at an intensity of 60-65% HRR, with 2-minute active recovery periods in between and a 5-minute cool down. The goal is to increase up to an intensity of around 80%-85% HRR by weeks 16 to 18. Intensity will be monitored with The Borg Rating Scale of Perceived Exertion (RPE). The resistance component will consist of upper body and lower body exercises (door frame rows, wall push-ups, glute bridges, triceps lifts and squat to calf rise) starting on week one with a set of 12 repetitions of each exercise, with 2-minute recovery in between exercises aiming to increase the number of sets and reducing the number of repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention group | Experimental | For this group (N=15) the intervention will consist of two supervised sessions per week, which include aerobic and resistance exercise, carried out as previuosly described. Receives: Other: Exercise intervention group |
| Control group (usual care) | No intervention | For the Control group or usual care (N=15), there will be no exercise sessions. Although, the same assessments as the intervention group will be carried out, at the same time-points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Feasibility Log of Eligibility of Participants.
To assess the feasibility of Eligibility of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the number of patients able to take part of the study after shared characteristics as a population have been assessed.
Measured: Eligibility will be recorded through study completion, an average of 15 months.
Quantitative Feasibility Log of Recruitment of Participants
To assess the feasibility of Recruitment of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information considering the number of randomized patients over the total number of months of recruitment time.
Measured: Recruitment will be recorded through study completion, an average of 15 months.
Quantitative Feasibility Log of Retention of Participants
To assess the feasibility of Retention of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information where Retention will be assessed by the formula based on the number of participants at the end of the set time period divided by the number of patients participating at the start of the set time period and multiplied by 100.
Measured: Retention will be recorded through study completion, an average of 15 months.
Quantitative Feasibility Log of Attendance of Participants
To assess the feasibility of Attendance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the number of sessions attended per each patient, throughout the program.
Measured: Retention will be recorded through study completion, an average of 15 months.
Quantitative and Qualitative Feasibility Log of Adverse Events of Participants
To assess the feasibility of Adverse Events of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative and qualitative information regarding details of reactions to the exercise intervention like any cardiorespiratory complications, musculoskeletal injury or pain or discomfort.
Measured: Adverse Events will be recorded through study completion, an average of 15 months.
Quantitative Feasibility Checklist of Fidelity
To assess the feasibility of Intervention Fidelity of delivering the protocol to breast cancer patients undergoing chemotherapy. This will be measured by Checklist of Fidelity e.g., if exercise sessions start on time, if patients complete the exercise session, if exercise sessions finish on time. Every item is rated on binary metric where "0" equates No and "1" equates yes.
Measured: Fidelity will be recorded will be recorded during the weeks of exercise intervention, (18 weeks).
Quantitative Feasibility Log of Adherence of Participants
To assess the feasibility of Adherence of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the percentage of classes attended out of the sessions planned.
Measured: Adherence will be recorded through study completion, an average of 15 months.
Quantitative Feasibility Log of Compliance (duration) of Participants
To assess the feasibility of Compliance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by the total number of minutes per exercise session achieved over all weeks of the exercise programme (duration); this quantitative information will be recorded at the Researchers Log.
Measured: Compliance will be recorded through study completion, an average of 15 months.
Quantitative Feasibility Log of Compliance (intensity) of Participants
To assess the feasibility of Compliance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by the intensity achieved by the patients during the intervention (%HRR); this quantitative information will be recorded at the Researchers Log.
Measured: Compliance will be recorded through study completion, an average of 15 months.
Quantitative Feasibility Log of Completion (retention) of Participants
To assess the feasibility of Completion (retention) of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the percentage of patients continuously attending and assessed at follow-up.
Measured: Completion (retention) will be recorded through study completion, an average of 15 months.
Qualitative Feasibility Log of Perception and experience of Participants
To assess the feasibility of the exercise protocol to breast cancer patients undergoing chemotherapy, Perception and experience of participants, as well as details of the impact this intervention had on their lives.will be recorded through an open-ended questions questionnaire. Information obtained will be recorded on the Researches Log.
Measured: Perception and experience of Participants will be recorded within one week after the last exercise session of each patient has taken place.
Secondary outcomes (12)
Echocardiographic scans - Left Ventricular Ejection Fraction (LVEF)
The Percentage of Left Ventricular Ejection Fraction (LVEF) will be measured as an outcome measure for cardiac function.
Measured: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Echocardiographic scans - Peak systolic global longitudinal strain (GLS)
The percentage of Peak systolic global longitudinal strain (GLS) will be measured as an outcome measure for cardiac function.
Measured: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Blood-borne biomarkers - Concentration of B-type natriuretic peptide (NT-ProBNP), Troponin I & T in blood samples.
B-type natriuretic peptide (NT-ProBNP), Troponin I \& T will be measured,these are blood markers of cardiovascular toxicity and inflammation.
Measured: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
12-lead Electrocardiogram (ECG)
This assessment will help measure the electrical activity of the heart. Parameters considered will be: measurements (Heart Rate, PR Interval, QRS Duration, QT Interval, Frontal Plane QRS Axis), Rhythm (if normal or abnormal, P waves), Conduction (Normal Sino-atrial, Atrio-ventricular, and Intraventricular conduction, PR interval and QRS duration), Waveform Description, P Wave (P duration, P amplitude, Frontal plane P wave axis), QRS Complex (duration, amplitude, Frontal plane leads, Precordial leads), and ST Segment and T wave
Measured: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Brachial artery flow-mediated dilation (FMD)
This test will be used to assess endothelium-dependent vasodilation, providing information about vascular function.
Measured: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Aortic Pulse Wave Velocity (PWV)
This test will be used to assess vascular function since it enables the direct assessment of aortic stiffness.
Measured: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
The six Minute Walking Test (6MWT)
This assessment will be an outcome measure for patients' functional capacity.
Measured: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Hand-grip Dynamometry
To assess muscle strength
Measured: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
30 seconds Sit-to-stand Tests
To assess muscle strength
Measured: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
The Functional Assessment of Chronic Disease Therapy
To measure self-reported fatigue and how it affects daily life in patients. It consists of a 13-item questionnaire, every item is rated on a scale of 0 to 4. The higher the result, the more fatigue the patient presents.
Measured: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)
The Functional Assessment of Cancer Therapy - Breast
To examine the impact of health status on the quality of life. It is a 37-item instrument which measures five domains of Health Related Quality of Life (HRQOL) in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS); every item is rated on a scale of 0 to 4. The higher the result, the lower the HRQOL.
Measured: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)
The 7-day Physical Activity Recall Scale
Is semi-structured questionnaire to estimate the individual's time spent in physical activity, strength, and flexibility activities for the last 7 days, allowing calculation of total energy expenditure and time spent in moderate, hard and very hard physical activity in units of energy which are metabolic equivalents (METs). The higher the mets, the higher the greater the amount of physical activity performed.
Measured: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants recruited will be cancer patients who attend to the Queen's Centre for Oncology and Haematology at Castle Hill Hospital, whose confirmed diagnosis is ER+ HER2- breast cancer, and whose chemotherapy regimen is 3 cycles of epirubicin and cyclophosphamide (EC) followed by 3 cycles docetaxel over a period of 18 weeks. They will be identified, screened and selected according to the study's inclusion and exclusion criteria, and then approached by their Consultant Clinical Oncologist in charge and/or the researcher. Patients will be offered the opportunity to be part of the study. Individuals will only participate if they have provided informed consent. Participants will be randomly allocated in a 1:1 ratio, either to intervention group, or the control group (usual care) by an unrestricted simple random sampling technique, until the maximum number of participants has been reached, which is a total of 15 individuals per group over a period of maximum 15 months.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595316
- Sponsor's protocol ID
- RS216 - 338687
- Status last verified
- Sep 2024
- First submitted
- 25 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Feasibility Trial of a Vigorous Intensity Aerobic Exercise and Resistance Training Intervention for Mitigating Chemotherapy Cardiotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06595316
- Acronym / sponsor ID
- RS216 - 338687
- Conditions
- Cardiotoxicity
- Keywords
- exercise, cardiotoxicity, exercise oncology, breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of HullUniversity, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Sep 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.
Chemotherapy is a common treatment for breast cancer but can damage the heart and blood vessels. Exercise, such as cycling, may stop chemotherapy from damaging the heart and blood vessels. Before the effects of exercise on the heart and blood vessels can be fully determined in a large trial, a small trial must first be carried out to assess if exercise can be included safely and practically during chemotherapy treatment.
This study is designed so that a group of breast cancer patients will exercise during their chemotherapy treatment, whilst another group does not exercise. Participants will be breast cancer patients from the Queen's Centre for Oncology and Haematology at Castle Hill Hospital. Suitable patients will be identified and approached by their Consultant Clinical Oncologist. If patients decide to take part, they will be randomly placed into groups ('exercise' or 'usual care') before starting chemotherapy. The exercise group will exercise for 50-60 minutes 2days/week in the Cardiac Rehabilitation Gym at Castle Hill Hospital during their chemotherapy treatment. Exercise will be supervised, consisting of repeated 5-minute bouts of high intensity cycling plus strength training. The usual care group will be given their normal chemotherapy only (no exercise). Both groups will take part in tests before they begin chemotherapy treatment. Tests assess heart and blood vessel health, fitness, strength, fatigue, and quality of life. The same tests will happen again during the intervention, after the intervention and 3-months later. Participants will also have to complete questionnaires to give their opinion of the study. The main point of the study is to determine if the exercise and tests are received well by patients, if recruitment is good, and if patients comply/adhere. This will inform a larger study which will assess if exercise maintains heart and vessel health during chemotherapy treatment.
Detailed description
Exercise has been shown to have benefits within cardio-oncology settings and evidence supports the use of exercise as a cardioprotective method in breast cancer. Several studies demonstrate evidence for positive effects of aerobic and resistance exercise to improve or alleviate the usual effects of chemotherapy on the heart and blood vessels in breast cancer. Despite the existing evidence that shows promising outcomes regarding exercise interventions for breast cancer patients undergoing chemotherapy who are at risk of developing cardiotoxicity due to treatment there is still insufficient evidence for exercise to be prescribed to this population as an adjuvant instrument to reduce cardiotoxicity.
Through this study we aim to build on the evidence base with the purpose of encouraging practice towards this approach. However, before a large definitive randomized controlled trial (RCT) can be conducted, the first step is to assess the feasibility of a high intensity exercise intervention during chemotherapy for breast cancer. This will inform the design of a large RCT which will determine the cardio-protective effects of the exercise intervention.
As this is a feasibility study the main outcome is to find out the practicalities of delivering the proposed exercise intervention in a healthcare setting by collecting information regarding eligibility, recruitment rates, retention, adherence, fidelity, and adverse events.
Secondary outcome measures will provide information about cardiac function, cardiovascular toxicity and inflammation, electrical activity of the heart, vascular function, functional capacity, muscle strength, fatigue, quality of life, and finally experiences and perceptions of patients after participating in the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants recruited will be cancer patients who attend to the Queen's Centre for Oncology and Haematology at Castle Hill Hospital, whose confirmed diagnosis is ER+ HER2- breast cancer, and whose chemotherapy regimen is 3 cycles of epirubicin and cyclophosphamide (EC) followed by 3 cycles docetaxel over a period of 18 weeks. They will be identified, screened and selected according to the study's inclusion and exclusion criteria, and then approached by their Consultant Clinical Oncologist in charge and/or the researcher. Patients will be offered the opportunity to be part of the study. Individuals will only participate if they have provided informed consent. Participants will be randomly allocated in a 1:1 ratio, either to intervention group, or the control group (usual care) by an unrestricted simple random sampling technique, until the maximum number of participants has been reached, which is a total of 15 individuals per group over a period of maximum 15 months.
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention group | Experimental | Other: Exercise intervention groupFor this group (N=15) the intervention will consist of two supervised sessions per week, which include aerobic and resistance exercise, carried out as previuosly described. |
| Control group (usual care) | No intervention | –For the Control group or usual care (N=15), there will be no exercise sessions. Although, the same assessments as the intervention group will be carried out, at the same time-points. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females between 18 to 75 years old.
- Confirmed early stage (I-III) ER+ HER2 - breast cancer diagnosis
- Undergoing adjuvant and neoadjuvant chemotherapy, consisting of epirubicin and cyclophosphamide (EC) followed by Docetaxel.
- No contraindications to engage in physical activity.
- Capable of giving informed consent.
Key exclusion criteria (3 listed)
- Participants with cognitive disorders
- Cancer metastases
- Uncontrolled or serious illnesses that might hamper patients' capacity of exercising
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 |
|---|---|---|
| Exercise intervention groupExercise will consist of two supervised sessions per week. Starting with vital signs monitoring (blood pressure, temperature, blood oxygen levels, heart rate). The aerobic component consists of a 5-minute warm-up, followed by 3 bouts of 4-minute cycling at an intensity of 60-65% HRR, with 2-minute active recovery periods in between and a 5-minute cool down. The goal is to increase up to an intensity of around 80%-85% HRR by weeks 16 to 18. Intensity will be monitored with The Borg Rating Scale of Perceived Exertion (RPE). The resistance component will consist of upper body and lower body exercises (door frame rows, wall push-ups, glute bridges, triceps lifts and squat to calf rise) starting on week one with a set of 12 repetitions of each exercise, with 2-minute recovery in between exercises aiming to increase the number of sets and reducing the number of repetitions. | Other | Exercise intervention group |
Primary outcome
Quantitative Feasibility Log of Eligibility of Participants.
Time frame: Eligibility will be recorded through study completion, an average of 15 months.
To assess the feasibility of Eligibility of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the number of patients able to take part of the study after shared characteristics as a population have been assessed.
Quantitative Feasibility Log of Recruitment of Participants
Time frame: Recruitment will be recorded through study completion, an average of 15 months.
To assess the feasibility of Recruitment of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information considering the number of randomized patients over the total number of months of recruitment time.
Quantitative Feasibility Log of Retention of Participants
Time frame: Retention will be recorded through study completion, an average of 15 months.
To assess the feasibility of Retention of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information where Retention will be assessed by the formula based on the number of participants at the end of the set time period divided by the number of patients participating at the start of the set time period and multiplied by 100.
Quantitative Feasibility Log of Attendance of Participants
Time frame: Retention will be recorded through study completion, an average of 15 months.
To assess the feasibility of Attendance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the number of sessions attended per each patient, throughout the program.
Quantitative and Qualitative Feasibility Log of Adverse Events of Participants
Time frame: Adverse Events will be recorded through study completion, an average of 15 months.
To assess the feasibility of Adverse Events of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative and qualitative information regarding details of reactions to the exercise intervention like any cardiorespiratory complications, musculoskeletal injury or pain or discomfort.
Quantitative Feasibility Checklist of Fidelity
Time frame: Fidelity will be recorded will be recorded during the weeks of exercise intervention, (18 weeks).
To assess the feasibility of Intervention Fidelity of delivering the protocol to breast cancer patients undergoing chemotherapy. This will be measured by Checklist of Fidelity e.g., if exercise sessions start on time, if patients complete the exercise session, if exercise sessions finish on time. Every item is rated on binary metric where "0" equates No and "1" equates yes.
Quantitative Feasibility Log of Adherence of Participants
Time frame: Adherence will be recorded through study completion, an average of 15 months.
To assess the feasibility of Adherence of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the percentage of classes attended out of the sessions planned.
Quantitative Feasibility Log of Compliance (duration) of Participants
Time frame: Compliance will be recorded through study completion, an average of 15 months.
To assess the feasibility of Compliance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by the total number of minutes per exercise session achieved over all weeks of the exercise programme (duration); this quantitative information will be recorded at the Researchers Log.
Quantitative Feasibility Log of Compliance (intensity) of Participants
Time frame: Compliance will be recorded through study completion, an average of 15 months.
To assess the feasibility of Compliance of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by the intensity achieved by the patients during the intervention (%HRR); this quantitative information will be recorded at the Researchers Log.
Quantitative Feasibility Log of Completion (retention) of Participants
Time frame: Completion (retention) will be recorded through study completion, an average of 15 months.
To assess the feasibility of Completion (retention) of delivering the prescribed exercise protocol to breast cancer patients undergoing chemotherapy. This will be measured by a Researchers Log which will include quantitative information regarding the percentage of patients continuously attending and assessed at follow-up.
Qualitative Feasibility Log of Perception and experience of Participants
Time frame: Perception and experience of Participants will be recorded within one week after the last exercise session of each patient has taken place.
To assess the feasibility of the exercise protocol to breast cancer patients undergoing chemotherapy, Perception and experience of participants, as well as details of the impact this intervention had on their lives.will be recorded through an open-ended questions questionnaire. Information obtained will be recorded on the Researches Log.
12 secondary outcomes
Echocardiographic scans - Left Ventricular Ejection Fraction (LVEF)
Time frame: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Echocardiographic scans - Peak systolic global longitudinal strain (GLS)
Time frame: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Blood-borne biomarkers - Concentration of B-type natriuretic peptide (NT-ProBNP), Troponin I & T in blood samples.
Time frame: These assessments will be performed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
12-lead Electrocardiogram (ECG)
Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Brachial artery flow-mediated dilation (FMD)
Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Aortic Pulse Wave Velocity (PWV)
Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
The six Minute Walking Test (6MWT)
Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
Hand-grip Dynamometry
Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
30 seconds Sit-to-stand Tests
Time frame: This will be assessed at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30).
The Functional Assessment of Chronic Disease Therapy
Time frame: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)
The Functional Assessment of Cancer Therapy - Breast
Time frame: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)
The 7-day Physical Activity Recall Scale
Time frame: It will be completed by the participants at baseline (week 0), within one week after the last exercise session of each patient has taken place (week 19), and 3 months after the last exercise session of each patient has taken place (week 30)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
John Saxton, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention group in people with Cardiotoxicity, run by University of Hull.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Ruilova Medina (+447466119052, s.e.ruilova-2019@hull.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Feasibility Log of Eligibility of Participants. (time frame: Eligibility will be recorded through study completion, an average of 15 months.). The study lists 11 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 19 Sep 2024.