An interventional study of Exercise intervention group in Cardiotoxicity, sponsored by University of Hull. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Hull · Not applicable, Interventional, and Supportive care
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.
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.
262 studies on the registry are indexed under Cardiotoxicity; 75 are open to participants now.
This study's planned enrollment of 30 is below the median of 93 across 137 interventional studies indexed under Cardiotoxicity.
Browse Cardiotoxicity studies →University of Hull is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Exercise intervention group
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Perception and experience of Participants will be recorded within one week after the last exercise session of each patient has taken place.
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.
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)
The percentage of Peak systolic global longitudinal strain (GLS) will be measured as an outcome measure for cardiac function.
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.
B-type natriuretic peptide (NT-ProBNP), Troponin I \& T will be measured,these are blood markers of cardiovascular toxicity and inflammation.
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)
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
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)
This test will be used to assess endothelium-dependent vasodilation, providing information about vascular function.
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)
This test will be used to assess vascular function since it enables the direct assessment of aortic stiffness.
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)
This assessment will be an outcome measure for patients' functional capacity.
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
To assess muscle strength
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
To assess muscle strength
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
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.
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
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.
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
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.
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)
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Hull